Drug Information

Drug Information Center
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Kerydin
The Food and Drug Administration (FDA) approved KerydinTM (tavaborole topical solution) for the treatment of toenail fungus. Source: FDA website
New Drug 07-07-14
Zydelig
The Food and Drug Administration (FDA) approved Zydelig® (idelalisib tablets) in combination with rituximab for individuals with relapsed chronic lymphocytic leukemia (CLL) for whom rituxumab alone would be considered appropriate therapy, as monotherapy for individuals with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior therapies and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. Source: FDA website
New Drug 07-23-14
Ruconest
The Food and Drug Administration (FDA) approved Ruconest® (C1 esterase inhibitor injection) for the treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Source: FDA website
New Drug 07-17-14
Acticlate
The Food and Drug Administration (FDA) approved ActiclateTM (doxycycline hyclate tablets) for the treatment of susceptible infections including adjunctive therapy in severe acne. Source: FDA website
New Drug 07-25-14
Rasuvo
The Food and Drug Administration (FDA) approved RasuvoTM (methotrexate subcutaneous auto-injection) for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis. Source: FDA website
New Drug 07-14-14
Octagam 10%
The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin intravenous injection) for the treatment of adults with chronic immune thrombocytopenic purpura (ITP). Source: FDA website
New Indication 07-15-14
Ryanodex
The Food and Drug Administration (FDA) approved Ryanodex® (dantrolene sodium injection) for the treatment of malignant hyperthermia (MH), along with appropriate supportive measures. Source: FDA website
New Drug 07-23-14
Targiniq ER
The Food and Drug Administration (FDA) approved TarginiqTM ER (oxycodone/naloxone tablets) for the treatment of severe pain. Source: FDA website
New Drug 07-24-14
NovoSeven RT
The Food and Drug Administration (FDA) approved NovoSeven® RT (coagulation factor VIIa, recombinant injection) for the treatment of bleeding episodes and perioperative management in individuals with Glanzmann's Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets. Source: FDA website
New Indication 07-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) for the treatment of individuals with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion). Source: FDA website
New Indication 07-28-14
Botox
The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) injection for the treatment of increased muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity
New Indications 03-09-10
Limbimax - Dietary Supplement
Nature & Health Co. is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. The FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing. The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product. If you have Libimax in your possession, stop using it immediately and contact your physician if you experience any problem that may be related to taking this product. Consumers are encouraged to submit a report of any serious adverse events that occurred with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Consumers should return any unused Libimax, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to contact Nature & Health directly at (714) 257-1800 Monday - Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions. Source: FDA Web Site
Drug Recall 04-29-09
Children and Infant Tylenol - Lot Recall
McNeil Consumer Healthcare is issuing a voluntary recall of certain lots of Children's and Infants' TYLENOL products that were manufactured between April 2008 and June 2008. The full list of recalled product lots is available at: http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc The company is issuing this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements. Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, the company has decided, as a precaution, to recall all products that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications. Published scientific literature regarding B. cepacia indicates that while ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or weakened immune systems. McNeil has conducted an assessment of post-marketing safety surveillance data and did not identify any safety signals or batch-related safety concerns for Infants' and Children's TYLENOL products over the time period, starting with the introduction of these batches, in or around April 2008. McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If you have a product affected valuby the recall, please contact McNeil Customer Care Center at 1- 800-962-5357 and they will send them a coupon for a new bottle. Source: FDA Web Site
Drug Recall 09-28-09
Unapproved & illegal H1N1 product sold on internet
The Food and Drug Administration (FDA) is warning consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients. These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur. The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Source: FDA website.
Drug Warning 10-20-09
Accusure Insulin Syringes
The Food and Drug Administration (FDA) and Qualitest Pharmaceuticals voluntarily issued a nationwide recall of all Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. The distributed syringes are of the following descriptions and national drug code (NDC) numbers: 28G 1/2cc, NDC 0603-6995-21; 28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21; 29G 1cc, NDC 0603-6998-21; 30G 1/2cc, NDC 0603-999-21; 30G 1cc, NDC 0603-7000-21; 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. NDC number can be found on the back of the syringe package. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. Source: FDA Web Site.
Drug Recall 10-29-09
Stelara
The Food and Drug Administration (FDA) has approved Stelara (ustekinumab), a biologic product for treating moderate to severe form of psoriasis in adults. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales. Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body's own antibodies as part of the immune system to stop the overproduction of skin cells and inflammation. Since Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer. The FDA is requiring the manufacturer to provide a medication guide for patients explaining the potential side effects. Source: FDA Web site.
New Drug 10-20-09
Folotyn
The Food and Drug Administration (FDA) has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL) which is often an aggressive type of non-Hodgkins lymphoma. Folotyn was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy. Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States. The most common adverse reactions seen with Folotyn were irritation or sores of the mucous membranes such as the lips, the mouth, and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea, and fatigue. Folotyn can harm a fetus and therefore, women should avoid becoming pregnant while being treated with this drug and pregnant women should be aware of the potential risks. Patients taking with Folotyn should take folate and vitamin B12 supplements to reduce mucous membrane irritation. Source: FDA Web Site
New Drug 10-21-09
Stiff Nights - Illegally Marketed
The Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as "dietary ingredients." The FDA has issued multiple alerts about these contaminated dietary supplements. Consumers should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death. In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules. Source: FDA Web Site
Drug Warning 11-10-09
Bodybuilding.com Brand Dietary Supplements
The Food and Drug Administration (FDA) and Bodybuilding.com voluntarily issued a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com. FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above. Customers are notified to return any unused products purchased on the Company’s site to the company. For instructions on how to return recalled products, please call 1-866-236-8417. A complete list of recalled products can be found at http://www.fda.gov/Safety/Recalls/ucm188929.htm. Source: FDA web site
Drug Recall 11-04-09
WinRho SDF
The Food and Drug Administration (FDA) has stated that there are reports of intravascular hemolysis (IVH) and its complications, including fatalities, in individuals being treated for immune thrombocytopenic purpura (ITP) with WinRho SDF (Rho[D] immune globulin intravenous [human]). The prescribing information will be revised. Source: FDA website.
Drug Warning 03-10-10
Trelstar 22.5 mg
The Food and Drug Administration (FDA) has approved Trelstar 22.5 mg (triptorelin pamoate) injection for twice yearly administration in the palliative treatment of advanced prostate cancer. Source: FDA website.
New Drug 03-11-10
Actemra
The Procter & Gamble Company is announcing a voluntary recall of three lots of its Vicks Sinex nasal spray. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals. P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom. P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture. In the US, the lot number affected is 9239028831. Product names: Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray. This lot number is listed on both the outer carton and the bottle. Consumers should simply discard the affected product as they would any OTC medicine. Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following number: From the United States, please call: 1.877.876.7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET) Source: FDA Web Site
New Drug 01-08-10
Pai You Guo - Drug Recall
GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The products listed above were sold and distributed nationwide via the internet. The FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585. Source: FDA Web Site
Drug Recall 11-16-09
ID Sports Dietary Supplements
IDS Sports and the Food and Drug Administration (FDA) is notifying consumers that five of the IDS's dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA considers to be steroids: "Madol," "Turinabol," "Superdrol," and/or "Androstenedione." Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. The recalled products were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules. If you have any of the products in your possession, stop using them immediately and contact your physician if you have experienced any problems that may be related to using the products. Source: FDA Website
Drug Recall 11-17-09
Moban
Endo Pharmaceuticals has announced that it is discontinuing Moban (molindone hydrochloride) 5, 10, 25, and 50 mg tablets. Existing inventories are expected to be depleted by the end of June 2010. Source: Facts and Comparisons.
Voluntary Withdrawal 1-22-10
Ampyra
The Food and Drug Administration (FDA) has approved Ampyra (dalfampridine) extended release oral tablets to improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking distance in clinical trials. Source: FDA website.
New Drug 1-22-10
Votrient
The Food and Drug Administration (FDA) has approved Votrient (pazopanib) for the treatment of kidney cancer. Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive. Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease. Adverse reactions include diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache. Votrient can also cause severe and fatal liver toxicity. You should have blood tests before and during treatment with this medication to monitor liver function. Since Votrient can harm a fetus, it should not be used during pregnancy. Votrient has also been associated with heart rhythm irregularities. Patients receiving Votrient should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm. Source: FDA Web Site
New Drug 11-17-09
Generic Prevacid
Prevacid is now available in a generic formulation. Lansoprazole, generic for Prevacid, is the second drug in a class of widely used medications called proton pump inhibitor to be available as a generic. Like other proton pump inhibitors, lansoprazole works by blocking the production of acid in the stomach and is used to treat conditions like heart burn, ulcers, and gastroesophageal reflux disease (GERD). A generic drug is equivalent to its brand name counterpart in its quality, performance characteristics, intended use, dosage form, strength, and how it is taken. Generics typically cost only a fraction of the brand name drug because generic manufacturers do not have the same expenses from researching, developing, and advertising the drug. For this reason, generic drugs offer consumer a safe and cost-effective alternative. Source: Facts and Comparisons, Washington Post
New Generic 11-17-09
RockHard Weekend (RHW) - Lot Recall
RockHard Laboratories is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers: Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12) ** 3ct Bottle: R417 0509 (exp: 09/12) ** 8ct Bottle: T237-0509 (exp: 06/12) ** RockHard Laboratories was informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. RHW is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RHW to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process. Source: FDA Web Site
Drug Recall 11-18-09
Prilosec and Plavix Drug Interaction
The Food and Drug Administration (FDA) has new data showing that omeprazole (Prilosec and Prilosec OTC) -- a medicine used to reduce stomach acid -- reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medicines are taken by the same patient. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. This effect is called a drug interaction and it occurs because omeprazole blocks the conversion of clopidogrel into its active form. Since clopidogrel can cause bleeding in the stomach, medications like omeprazole may be used in combination to reduce the production of stomach acid, and prevent stomach bleeding. Omeprazole is available by prescription and as an over-the-counter (OTC) medication to treat frequent heartburn. The FDA wants to emphasize the following information for patients using clopidogrel: *** Patients using clopidogrel should consult with their healthcare provider if they are currently taking or considering taking omeprazole, including Prilosec OTC. *** Both clopidogrel and omeprazole can provide significant benefits to patients, and patients should always consult with their healthcare professional before starting or stopping any medication. *** It is very important that patients talk with their healthcare professional about any over-the-counter (OTC) drugs they are taking before starting or while using clopidogrel . Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids (such as Maalox or Mylanta) and most acid reducers, such as Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine) because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel. However, Tagamet and Tagamet HB (cimetidine) should not be used. Ranitidine and famotidine are available by prescription and OTC and antacids are available OTC. The manufacturers of clopidogrel have agreed to look at other possible drug interactions with clopidogrel. In the meantime, the clopidogrel label will be updated with new warnings on omeprazole and other drugs that could interact with clopidogrel in the same way. When more information becomes available, FDA will communicate any additional recommendations or conclusions on the use of clopidogrel. Source: FDA Web Site
Drug Warning 11-18-09
Meridia
The Food and Drug Administration (FDA) has stated that a review of additional data shows an increased risk of heart attack and stroke in individuals with a history of cardiovascular disease who are taking Meridia (sibutramine). A new contraindication will be added to the drug label stating that Meridia should not be used in those with a history of cardiovascular disease. Source: FDA website.
Drug Warning 1-21-10
Velcade
The Food and Drug Administration (FDA) and the manufacturer have announced revisions to the Prescribing Information for Velcade with regards to dosage adjustment in hepatic impairment. Source: FDA website.
Drug Warning 1-26-10
Victoza
The Food and Drug Administration (FDA) has approved Victoza (liraglutide) subcutaneous once daily injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended as first-line therapy. Source: FDA website.
New Drug 1-25-10
Lamictal XR
The Food and Drug Administration (FDA) has approved Lamictal XR (lamotrigine extended release) tablets as once daily, add-on therapy for primary generalized tonic-clonic seizures in individuals 13 years and older. Source: FDA website.
New Indications 01-29-10
Videx/Videx EC
The Food and Drug Administration (FDA) has stated that a rare, but serious, liver condition known as non-cirrhotic portal hypertension has been reported in individuals using Videx or Videx EC. The FDA has revised the Warning and Precautions section of the prescribing information to warn of this association. Source: FDA website.
Drug Warning 1-29-10
Vicks Sinex Nasal Spray - Lot Recall
The Procter & Gamble Company is announcing a voluntary recall of three lots of its Vicks Sinex nasal spray. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals. P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom. P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture. In the US, the lot number affected is 9239028831. Product names: Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray. This lot number is listed on both the outer carton and the bottle. Consumers should simply discard the affected product as they would any OTC medicine. Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following number: From the United States, please call: 1.877.876.7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET) Source: FDA Web Site
Drug Recall 11-19-09
Tykerb
The Food and Drug Administration (FDA) has approved an expanded indication for use of Tykerb in combination with Femara to treat hormone positive and HER2-positive advanced breast cancer. Source: FDA website.
New Indications 1-29-10
Xiaflex
The Food and Drug Administration (FDA) has approved Xiaflex (collagenase clostridium histolyticum) injection for the treatment of adult patients with Dupuytren's contracture with a palpable cord. Source: FDA website.
New Drug 02-02-10
Zyprexa
The Food and Drug Administration (FDA) has stated that there will be revisions to the Prescribing Information for Zyprexa (olanzapine) regarding the possible long-term risks associated with its use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder. These risks include weight gain and hyperlipidemia. Source: FDA website.
Drug Warning 1-29-10
Oleptro
The Food and Drug Administration FDA has approved Oleptro trazodone extended release tablets as a once daily treatment for major depressive disorder MDD in adults. Source: FDA website.
New Drug 02-03-10
Crestor
The Food and Drug Administration (FDA) has approved Crestor (rosuvastatin) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD). Source: FDA website.
New Indications 02-08-10
Tysabri
The Food and Drug Administration (FDA) has stated that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri (natalizumab) infusions that are administered. The drug label and patient Medication Guide will be updated with this new safety information. Source: FDA website.
Drug Warning 02-05-10
Benicar
The Food and Drug Administration (FDA) has approved Benicar (olmesartan medoxomil) for the treatment of hypertension in children and adolescents 6-16 years of age. Source: FDA website.
New Indications 02-11-10
Norvir
The Food and Drug Administration (FDA) has approved a heat-stable formulation of Norvir (ritonavir) tablets for the treatment of HIV infection. The new tablet can be stored at room temperature rather than in a refrigerator. Source: FDA website.
New Drug 02-10-10
Erythropoiesis-Stimulating Agents
The Food and Drug Administration (FDA) has stated that all erythropoiesis-stimulating agents (ESAs) must be used under a risk management program that includes the requirement that only hospitals and healthcare professionals who have enrolled and completed training in the risk management program will be able to prescribe and dispense ESAs to individuals with cancer. Source: FDA website.
Drug Warning 02-16-10
Rituxan
The Food and Drug Administration (FDA) has approved Rituxan (rituximab) for use in combination with fludarabine and cyclophosphamide for individuals with previously untreated and previously treated chronic lymphocytic leukemia (CLL). Source: FDA website.
New Indications 02-18-10
Exjade
The Food and Drug Administration (FDA) has communicated about recent changes to the Prescribing Information for Exjade (deferasirox) regarding the risk of renal impairment or failure, hepatic impairment or failure and gastrointestinal hemorrhage. Source: FDA website.
Drug Warning 02-18-10
Long-acting beta-agonists
The Food and Drug Administration (FDA) has stated that the agency is requiring a risk management strategy (REMS) and class labeling changes for all products that contain a long-acting beta-agonist (LABA) including Foradil, Advair, Serevent, and Symbicort. These changes are based on the analyses of trials indicating an increased risk of severe exacerbation of asthma leading to hospitalizations as well as death in some individuals. Source: FDA website.
Drug Warning 02-18-10
Mirapex ER
The Food and Drug Administration (FDA) has approved Mirapex ER (pramipexole ER) tablets for the signs and symptoms of advanced idiopathic Parkinsons disease. Source: FDA website.
New Drug 02-22-10
Menveo
The Food and Drug Administration (FDA) has approved a vaccine for the active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 11-55 years of age. Source: FDA website.
New Drug 02-22-10
Cayston
The Food and Drug Administration (FDA) has approved Cayston (aztreonam for inhalation solution) to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Source: FDA website.
New Drug 02-23-10
Avandia
The Food and Drug Administration (FDA) has stated that the agency is reviewing data from the RECORD trial and other data regarding possible cardiovascular risks with Avandia (rosiglitazone). No conclusions or recommendations are being made at this time. Source: FDA website.
Drug Warning 02-22-10
Invirase
The Food and Drug Administration (FDA) has stated that the agency is reviewing clinical trial data regarding a potentially serious effect on heart rhythms when Invirase (saquinivir) is used in combination with Norvir (ritonavir). The FDA will provide an update as soon as their review is complete. Source: FDA website.
Drug Warning 02-23-10
Prevnar 13
The Food and Drug Administration (FDA) has approved Prevnar 13 (pneumococcal 13-valent conjugate vaccine) for the prevention of invasive pneumococcal disease and otitis media in children 6 weeks through 5 years of age. Source: FDA website.
New Drug 02-24-10
Vpriv
The Food and Drug Administration (FDA) has approved Vpriv (velaglucerase alfa for injection) for the treatment of children and adults with type 1 Gaucher disease. Source: FDA website.
New Drug 02-26-10
Exalgo
The Food and Drug Administration (FDA) has approved Exalgo (hydromorphone extended release tablets) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Source: FDA website.
New Drug 03-02-10
Hizentra
The Food and Drug Administration (FDA) has approved Hizentra (immune globulin 20% liquid for subcutaneous injection) for the once weekly treatment of primary immunodeficiency. Source: FDA website.
New Drug 03-05-10
Norditropin FlexPro
The Food and Drug Administration (FDA) has approved Norditropin FlexPro (somatropin injection) in a pre-filled injection pen for use in children and adults with growth hormone disorders. Source: FDA website.
New Drug 03-03-10
Bisphosphonates
The Food and Drug Administration (FDA) has stated that the agency is conducting an ongoing review of bisphosphonate use and the risk of atypical subtrochanteric femur fractures. At this point, the data do not show a clear connection and patients should continue taking their medication unless told by their healthcare professional to stop. Source: FDA website.
Drug Warning 03-11-10
Plavix
The Food and Drug Administration (FDA) has stated that a Boxed Warning has been added to the prescribing information for Plavix (clopidogrel) regarding reduced effectiveness in poor metabolizers. Source: FDA website.
Drug Warning 03-12-10
Silenor
The Food and Drug Administration (FDA) has approved Silenor (doxepin) 3 mg and 6 mg tablets for the treatment of insomnia characterized by difficulty with sleep maintenance. Source: FDA website.
New Drug 03-17-10
Carbaglu
The Food and Drug Administration (FDA) has approved Carbaglu (carglumic acid) tablets for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. Source: FDA website.
New Drug 03-18-10
Zocor
The Food and Drug Administration (FDA) has stated they have notified healthcare professionals and consumers that there is an increased risk of muscle injury in individuals taking the highest approved dose of Zocor based on a review of a large clinical trial and other sources. Source: FDA website.
Drug Warning 03-19-10
Cleviprex
The December 2009 recall of Cleviprex (clevidipine butyrate) injection due to the possible presence of particulate matter has been expanded to include four additional lots. The four additional lots are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. Source: FDA website.
Drug Recall 03-18-10
Mirapex ER
The Food and Drug Administration (FDA) has approved Mirapex ER (pramipexole extended-release) tablets for the treatment of signs and symptoms of early Parkinsons disease. Source: FDA website.
New Indications 03-19-10
Rotarix
The Food and Drug Administration (FDA) has recommended that the use of Rotarix, a vaccine for the prevention of rotavirus disease, be temporarily suspended. The FDA has confirmed that DNA from porcine circovirus type 1 (PCV1) has been detected in the vaccine. There is no evidence of a safety risk at this time but the FDA will continue to investigate. For patients who have received one dose of Rotarix, the Centers for Disease Control (CDC) advises that the vaccination series can be completed with RotaTeq for the next two doses. Source: FDA website.
Drug Warning 03-22-10
Topical Acne Cream
CSI USA, Inc. is issuing a voluntary nationwide recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart). These products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia. After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall. No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall. If you have purchased the affected product(s), stop using it immediately. You may obtain a full refund by mailing the tube(s), or proof of purchase, to: CSI USA,
Drug Recall 11-18-08
Differin
The Food and Drug Administration (FDA) has approved Differin (adapalene 0.1%) lotion formulation for the treatment of acne vulgaris in individuals > 12 years of age. Source: FDA website.
New Drug 03-17-10
Xifaxan 550 mg
The Food and Drug Administration (FDA) has approved Xifaxan 550 mg tablets for the reduction in risk of recurrence of hepatic encephalopathy in patients > 18 years of age with advanced liver disease. Source: FDA website.
New Indications 03-25-10
Zyclara
The Food and Drug Administration (FDA) has approved Zyclara (imiquimod cream) for the treatment of actinic keratosis of the full face or balding scalp in immunocompetent adults. Source: FDA website.
New Drug 03-25-10
Stalevo
The Food and Drug Administration (FDA) has announced that it is evaluating Stalevo (carbidopa/levodopa/entacapone) clinical study data that suggests individuals taking this medication to treat Parkinson's disease may be at an increased risk for cardiovascular (CV) events including heart attack, stroke, and CV death compared with Sinemet (carbidopa/levodopa). The review is ongoing and healthcare professionals should evaluate the cardiovascular status of individuals taking Stalevo, especially if they have a history of CV disease. Individuals should not discontinue treatment with Stalevo unless told to do so by their healthcare professional. Source: FDA website
Drug Warning 08-20-10
Asclera
The Food and Drug Administration (FDA) has approved Asclera (polidocanol injection) for the treatment of varicose veins. Source: FDA website.
New Drug 03-30-10
TachoSil
The Food and Drug Administration (FDA) has approved TachoSil (absorbable fibrin sealant patch) as an adjunct to hemostasis for use in cardiovascular surgery when control of bleeding by standard surgical techniques is not effective. Source: FDA website.
New Drug 04-06-10
Morphine Sulfate - Lot Recall
Ethex is recalling specific lots of generic morphine sulfate immediate and extended release tablets due to the possibility of oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage. Overdoses of morphine sulfate can have serious or life-threatening consequences, including difficulty or lack of breathing and low blood pressure. The morphine sulfate lots involved in the recall were shipped prior to May 22, 2008 and are as follows: Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010 Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011 Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011 The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse. If you have any questions about this recall, please contact your physician, pharmacist, other health care providers, or the ETHEX Customer Service department at 314-646-3751 or via email at customer-service@ethex.com. If you believe that you've experience adverse reaction to morpine sulfate, contact your physician and/or health care provider immediately. Source: FDA Web Site
Drug Recall 11-10-08
Dextroamphetamine Sulfate -- Lot Recall
Ethex is recalling specific lots of generic dextroamphetamine sulfate tablets due to the possibility of oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage. Overdoses of dextroamphetamine can have serious or life-threatening consequences, including rapid heart rate and high blood pressure. The dextroamphetamine sulfate lots involved in the recall were shipped prior to May 22, 2008 and are as follows: Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011 The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side. If you have any questions about this recall, please contact your physician, pharmacist, other health care providers, or the ETHEX Customer Service department at 314-646-3751 or via email at customer-service@ethex.com. If you believe that you've experienced adverse reaction to dextroamphetamine sulfate, contact your physician and/or health care provider immediately. Source: FDA Web Site
Drug Recall 11-10-08
Generic Paxil & Paxil CR
Paroxetine is now available as generic for Paxil. Paroxetine belongs to a class of medication known as selective serotonin reuptake inhibitor (SSRI). Drugs in this class work by increasing the activity of a chemical known as serotonin in the brain. Indications for this antidepressant includes major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, and social phobia. Paroxetine is usually taken in the morning, with or without food. Side effects may include sweating, constipation, diarrhea, loss of appetite, dry mouth, insomnia, dizziness, sexual changes, somnolence, and and serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking, and sudden loss of consciousness). As with all antidepressants, paroxetine has the potential increased risk for suicidal thinking and behavior in children, adolescents, and young adults. People with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in the course of treatment or when the dosage is changed. Children as well as adults taking antidepressants may have more suicidal thoughts and actions. It is important that you talk to your pharmacist and physician if you are taking other medications, vitamins, or herbal supplements as they may interact with paroxetine. A generic drug is equivalent to its brand name counterpart in its quality, performance characteristics, intended use, dosage form, strength, and how it is taken. Generics typically cost only a fraction of the brand name drug because generic manufacturers do not have the same expenses from researching, developing, and advertising the drug. For this reason, generic drugs offer consumer a safe and cost-effective alternative. Source: FDA web site and Drug Facts and Comparisons
New Generic 09-24-08
Oxycontin
The Food and Drug Administration (FDA) has approved a new tamper-resistant formulation of Oxycontin (oxycodone controlled- release) which has been designed to discourage abuse. It is indicated for the management of moderate to severe pain in opioid- tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period of time. Source: FDA website.
New Drug 04-05-10
Metoclopramide
The U.S. Food and Drug Administration (FDA) is alerting consumers of the risk of developing a movement disorder called tardive dyskinesia associated with long-term or high dose use of metoclopramide. Metoclopramide is a medication used to speed up muscle contractions in the digestive system to help with short-term treatment of gastroesophageal reflux and to increase the rate at which the stomach empties into the intestines for patients with diabetic gastroparesis. Tardive dyskinesia is a movement disorder characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. People at greatest risk for developing this side effect include the elderly, especially older women, and people who have been on the drug for a long time. The FDA is requiring that all manufacturers of drugs that contain metoclopramide provide patients with a medication guide that discusses this risk. The FDA is advising that metoclopramide be reserved for rare cases where the benefit is believed to outweigh the risks and treatment with metoclopramide should not exceed three months. Source: FDA Web Site
Drug Warning 02-28-09
Dextroamphetamine Sulfate 5mg tablet - Lot Recall
ETHEX Corporation is announcing a voluntarily recall on three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain up to twice the normal, labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet indented with "ETHEX" and "311" on one side. Taking a higher than expected dose of Dextroamphetamine Sulfate could increase your risk of developing adverse effects such as abnormally fast heart rate rhythm, high blood pressure, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, upset stomach, and dry mouth may be increased. ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed. Please be aware that there are multiple companies in the United States producing and marketing generic versions of Dextroamphetamine Sulfate 5 mg tablets. Make sure you check your medicines to determine the source of their tablets. If you have any questions regarding this recall, please contact your pharmacist, doctor, or the ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or send an email to: customer-service@ethex.com. Source: FDA Web Site
Drug Recall 10-20-08
Infant's Mylicon Gas Relief Dye Free Drops
Johnson & Johnson * Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately. The two lots of Infants' MYLICON GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are: Product Code # 71683791111-1, lot # SMF007, expires 09/10 Product Code # 71683791111-1, lot # SMF008, expires 09/10 Lot numbers can be found on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle. If you've purchased Infants' MYLICON GAS RELIEF DYE FREE drops non-staining included in this recall, you should immediately stop using the product and contact the company at 1-800-222-9435 (Monday through Friday, 8:00 a.m. to 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund. Infants' MYLICON drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods. The recall does not affect any Original Infants' MYLICON GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON GAS RELIEF DYE FREE drops non-staining (1/2 oz. size). Source: FDA Web Site
Drug Recall11-12-08
Oral Sodium Phosphate Product - Drug Warning
The FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. Acute phosphate nephropathy is a form of acute kidney injury that is associated with permanent renal function impairment. Acute phosphate nephropathy is a rare and serious adverse event. Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OSPs include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]). As a result of new safety information received, the FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturers include a Medication Guide with each prescription dispensed to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy. In light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Bowel cleansing prior to colonoscopy or other procedures should be done with prescription product from a healthcare professional. Source: FDA Web Site
Drug Warning12-17-08
Medicated Patches with Metal Backing during MRI
Certain transdermal patches (medicated patches applied to the skin) may contain aluminum or other metals in the backing of the patches. During an MRI scan, these patches which contain metal can overheat and cause skin burns in the immediate area of the patch. Transdermal patches slowly deliver medicines through the skin. Some patches contain metal in the layer of the patch that is not in contact with the skin (the backing). The metal in the backing of these patches may not be visible. The labeling for most of the medicated patches that contain metal in the backing provides a warning about the risk of burns if the patch is not removed before an MRI scan. However, not all transdermal patches that contain metal have this warning in the labeling. The Food and Drug Administration (FDA) is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns during an MRI scan. Until this review is complete, do the following: **** Tell the doctor referring you for an MRI scan that you are using a patch (including nicotine patches) and why you are using it (such as for pain, smoking cessation, or hormone) **** Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure **** Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment. Source: FDA Web Site
Drug Warning03-05-09
Toviaz
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Toviaz will be available by prescription only, as an extended release tablet and should be taken once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults. In clinical studies, Toviaz demonstrated meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo. Common side effects associated with Toviaz include dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder. Toviaz is not recommended in doses above 4 mg in patients with severe reduction in kidney function or in patients taking medications, such as ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation. Source: FDA web site
New Drug03-08-09
Heparin
The Food and Drug Administration (FDA) has communicated that at the agencys request, laboratory studies have been performed that demonstrate that heparin sodium made under the new United States Pharmacopeia (USP) monograph has approximately 10% less anticoagulant activity compared to heparin prepared using the previous USP monograph. The FDA continues to recommend that clinical judgment be used in determining the dose of heparin for an individual. Source: FDA website.
Drug Warning04-07-10
Propylthiouracil
The Food and Drug Administration (FDA) has added a Boxed Warning to the prescribing information for propylthiouracil with regards to reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric individuals. Source: FDA website
Drug Warning04-21-10
Tarceva
The Food and Drug Administration (FDA) has approved Tarceva (erlotinib) for the maintenance treatment of advanced non-small cell lung cancer. Source: FDA website.
New Indications04-16-10
Pancreaze
The Food and Drug Administration (FDA) has approved Pancreaze (pancrelipase delayed-release capsules) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. Source: FDA website.
New Drug04-12-10
Oravig
New Drug04-16-10
GnRH Agonists
The Food and Drug Administration (FDA) has stated that the agency is conducting an ongoing review of gonadotropin-releasing hormone (GnRH) agonists that is suggesting there is an increased risk of diabetes and certain cardiovascular (CV) diseases in men who are treated with GnRH agonists for prostate cancer. Patients should be monitored for development of diabetes and CV disease; however, they should not discontinue treatment with GnRH agonists unless told to do so by their physician. The FDA has not yet made any conclusions about this potential risk. Source: FDA website.
Drug Warning05-07-10
ReliOn Insulin Syringe - Lot Recall
Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. The recall applies to the following lot number and product information: -- Lot Number 813900 -- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall. These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy for a replacement product. If you are using ReliOn syringes, please check the packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900. If you suspect that you have the recalled product and wish to obtain additional information, please contact Covidien at 866-780-5436 or www.relion.com/recall. The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008. During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin. Source: FDA web site
Drug Recall11-06-08
Vimovo
The Food and Drug Administration (FDA) has approved Vimovo (naproxen/esomeprazole) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in individuals at risk of developing non-steroidal anti-inflammatory drug associated gastric ulcers. Source: FDA website.
New Drug04-30-10
Provenge
The Food and Drug Administration (FDA) has approved Provenge (sipuleucel-T suspension for intravenous infusion) for the treatment of advanced prostate cancer. Source: FDA website.
New Drug04-29-10
Natazia
The Food and Drug Administration (FDA) has approved Natazia (estradiol valerate/dienogest) tablets for the prevention of pregnancy. Source: FDA website.
New Drug05-06-10
Vivitrol
The Food and Drug Administration (FDA) has announced the approval of Vivitrol (naltrexone extended-release monthly injection) for the treatment and prevention of relapse after detoxification in opioid-dependent patients. Source: FDA website.
Drug Warning10-12-10
Propafenone tablets -- Lot Recall
Ethex is recalling specific lots of generic propafenone due to the possibility of oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage. Overdoses of propafenone can have serious or life-threatening consequences, including irregular heartbeat and low blood pressure. The propafenone lots involved in the recall were shipped prior to May 22, 2008 and are as follows: Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011. Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011. Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011. Propafenone Hydrochloride 150 mg tablet is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse. If you have any questions about the recall, please contact your physician, pharmacist, other health care providers, or the ETHEX Customer Service department at 314-646-3751 or via email at customer-service@ethex.com. If you believe that you've experience adverse reaction to propafenone, contact your physician and/or health care provider immediately. Source: FDA Web Site
Drug Recall11-10-08
Isosorbide Mononitrate Extended Release - Lot Recall
Ethex is recalling specific lots of generic isosorbide mononitrate extended release tablets due to the possibility of oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage. Overdoses of isosorbide mononitrate can have serious or life-threatening consequences, including fainting and low blood pressure. The Isosorbide mononitrate extended release lots involved in the recall were shipped prior to May 22, 2008 and are as follows: Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009 Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009 The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side. If you have any questions about this recall, please contact your physician, pharmacist, other health care providers, or the ETHEX Customer Service department at 314-646-3751 or via email at customer-service@ethex.com. If you believe that you've experienced adverse reaction to isosorbide mononitrate, contact your physician and/or health care provider immediately. Source: FDA Web Site
Drug Recall11-10-08
CIP-Tramadol ER
The Food and Drug Administration (FDA) has approved CIP-Tramadol ER, an extended release tramadol formulation, for the treatment of moderate to moderately severe chronic pain in adults. The brand name has not been determined at this time. Source: FDA website.
New Drug05-10-10
Cough and Cold Products in Children
In an effort to prevent misuse and to better inform consumers about the safe and effective use of nonprescription over-the-counter (OTC) cough and cold products in children, these products will soon receive new labeling changes to say DO NOT USE in children under the age of 4. Additional changes will include the introduction of new child-resistant packaging and new measuring devices for use with the products. If you have any questions regarding this announcement or are not sure about how much medicine to give to your child, consult with your doctor or pharmacist. Until further information is available, the FDA is recommending the following: * Do not give children medications labeled for only adults. * Talk to your healthcare professional if you have any questions about using cough or cold medicines in children. * Choose OTC cough and cold medicines with child-resistant safety caps, when available. Remember to close the cap tightly and store the medicines out of the sight and reach of children after each use. * Check the active ingredients section of the DRUG FACTS label of the medicine to help you understand what symptoms in the medicines are intended to treat. Cough and cold medicines often have more than one active ingredient. * Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of active ingredients or your child could get too much of an ingredient and that may hurt him or her. For example, do not give a child more than one medicine that has a decongestant. * Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. Overuse or misuse can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events. * Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. * Understand that using OTC cough and cold medicines do not cure the cold or cough, they only treat symptoms such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick. Source: FDA Web Site
Drug Warning10-20-08
Zortress
The Food and Drug Administration (FDA) has approved Zortress (everolimus tablets) for the prevention of rejection of kidney transplants in adults at low to moderate immunologic risk. Source: FDA website.
New Drug04-22-10
Promacta
The Food and Drug Administration (FDA) has stated there is a new safety finding with regards to individuals with thrombocytopenia due to chronic liver disease who are being treated with Promacta (eltrombopag), a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura. There are reports from a clinical trial of an imbalance of thrombosis of the portal venous system in individuals treated with Promacta compared with placebo. This new information will be included in the product labeling. Source: FDA website
Drug Warning05-13-10
STARCAPS Diet System - Lot Recall
Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 - 84810, sold in 30 capsule plastic bottles. This lot of STARCAPS was found to contain an undeclared drug ingredient -- Bumetanide which is a diuretic available only by prescription. Bumetanide is also not listed on the product label as an ingredient in this product. Bumetanide is a diuretic approved for the treatment of edema (swelling caused by fluid build up in the body's tissues) associated with congestive heart failure, liver and kidney disease including nephrotic syndrome. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. You should not take Bumetanide if you are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. This medication may also increase your risk of hypotension (low blood pressure), fainting (syncope) and result in injury if you have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide. To date, this recall only applies to Lot 12/2011 - 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled. The recalled lot totaling 1,974 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales. If you have purchased STARCAPS Lot 12/2011 - 84810, stop using it immediately and return it to Balanced Health Products, Inc at the address on the product label. If you have any questions regarding this recall, please contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday. If you believe you've experience adverse events with any lots of this product, contact your health care provider immediately. Source: FDA Web Site
Drug Recall11-26-08
Zhen De Shou Fat Loss Capsules
Fashion Sanctuary is recalling all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. The recall was initiated after notification by the Food and Drug Administration (FDA) that lab analysis of Zhen De Shou samples found the product to contain undeclared sibutramine, making it an unapproved drug. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product was primarily distributed in the U.S and sold via the Internet. It is sold in a box with an inner foil pouch. Inside the pouch is a blister pack containing light and dark green capsules. This recall affects all lot codes and use by dates. No illnesses or injuries have been reported to date in connection with this product. If you have purchased this product stop using it immediately and contact the firm at zhendeshourecall@gmail.com to receive further instructions for returning the product or if you have any questions. Source: FDA Web Site
Drug Recall11-25-08
Metronidazole
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection 500 mg/100 mL manufactured by Claris Lifesciences and distributed by Sagent. The recall is due to non-sterility found in two lots. The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019. Source: FDA website.
Drug Recall05-17-10
Topical Anesthetics
The Food and Drug Administration (FDA) is issuing an advisory to remind patients, caregivers, and healthcare professionals about the potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from medical tests and conditions. In February 2007, the FDA issued a public health advisor which described the deaths of two young women who used topical anesthetics prior to laser hair removal. Now, FDA is aware that lidocaine, a type of topical anesthetic, was studied to see if it may reduce discomfort during breast mammography. The FDA remains concerned about the potential for topical anesthetics to cause serious and life-threatening adverse effects when applied to a large area of skin or when the area of application is covered. Topical anesthetics work by blocking pain sensation in the skin. Some of the medication in a topical anesthetic can pass through the skin into the blood stream. More of the medication will pass into the blood stream if the topical anesthetic is applied over a large area of the skin, if a large amount is applied, if it is applied to irritated or broken skin, or if the skin temperature increases. Skin temperature can increase during exercise, by covering the skin with a wrap, or with use of a heating pad. Under these circumstances, the amount of anesthetic medication that reaches the blood stream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death. There are several topical anesthetics available by prescription and over-the-counter. When used appropriately, these products may provide safe and effective pain relief. Before deciding to use a topical anesthetic for any purpose, talk to your doctors to determine if the desired amount of pain relief can be achieved safely with a topical anesthetic, or if a different treatment would be more appropriate. If a topical anesthetic is determined to be the best choice, use the lowest needed amount possible. If you and your doctor decide that a topical anesthetic needed, be sure to follow the following advice: *** use a topical anesthetic that contains the lowest amount possible of medication that will relieve the pain; *** apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur; *** do not apply the topical anesthetic to broken or irritated skin. *** ask your doctor what side effects are possible and how to lower your risk of having life-threatening side effects from anesthetic drugs. *** be aware that if wrapping or covering the skin with any type of material or dressing is recommended or considered, this can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present. Source: FDA Web site
Drug Warning01-16-09
Rotarix
On March 22, 2010, the Food and Drug Administration (FDA) recommended that the use of Rotarix (rotavirus vaccine), a vaccine for the prevention of rotavirus disease, be temporarily suspended. After a thorough review of available data, the FDA has now determined that it is appropriate to resume the use of Rotarix and to continue the use of RotaTeq. The FDA weighed the substantial benefits of the vaccine against the theoretical risk of porcine circovirus (PVC) in humans. The agency and the manufacturer will continue to investigate the findings of PCV in rotavirus vaccines. Source: FDA website.
Drug Warning05-16-10
Sprix
The Food and Drug Administration (FDA) has approved Sprix (ketorolac tromethamine nasal spray) formulation for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level. Source: FDA website.
New Drug05-17-10
Zymaxid
The Food and Drug Administration (FDA) approved Zymaxid (gatifloxacin ophthalmic solution 0.5%) for the treatment of bacterial conjunctivitis. Source: FDA website.
New Drug05-19-10
Xenazine
The U.S. Food and Drug Administration (FDA) has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington's disease. Currently there are no other drugs that are FDA-approved to treat chorea. Serious side effects reported with use of Xenazine include depression and suicidal thoughts and actions. Xenazine should not be used in patients who are actively suicidal or in patients with untreated depression. Concerns about the risk of suicide are heightened in all patients with Huntington's disease. Huntington's disease is a rare, inherited neurological disorder affecting about 1 in 10,000 people in the United States. The disease results from genetically programmed degeneration of brain cells. The deterioration causes uncontrolled movements, loss of intellectual faculties, and emotional disturbance. Huntington's disease is passed from parent to child through a gene mutation. Each child of a parent with the disease has a 50 percent chance of inheriting the mutation. About 30,000 people in the United States have Huntington's disease and another 200,000 are at risk of developing the condition. Symptoms commonly develop between ages 30 and 50. The disease progresses slowly and a person may live for another 15-20 years after the onset of symptoms. Xenazine decreases the amount of dopamine available to work at relevant synapses in the brain. Dopamine is a chemical that communicates between certain nerve cells in the brain. In patients with Huntington's disease, this system is overactive and results in the abnormal movements called chorea. Xenazine decreases the amount of dopamine available to interact with certain nerve cells, thereby decreasing the involuntary movements. The most common side effects reported by patients using Xenazine include insomnia, depression, drowsiness, restlessness and nausea. While the drug has been shown to decrease chorea in the short-term, it also showed slight worsening in mood, cognition, rigidity, and functional capacity in clinical trials. Family members or caregivers of patients taking the drug should pay attention to all of the facets of the disease. The FDA requires that every prescription for this medication be dispensed with the Medication Guide to inform patients and their caregivers about the risks of depression, suicidal thoughts and actions, and other side effects. Source: FDA Web Site
New Drug12-10-08
Vagifem 25 mcg
Novo Nordisk has announced the discontinuation of Vagifem (estradiol hemihydrate) 25 mcg vaginal tablets due to medical recommendations to use the lowest effective doses of estrogen possible to treat atrophic vaginitis due to menopause. The 10 mcg dose will continue to be available. The discontinuation will be effective July 30, 2010 but the product will be available through pharmacies and wholesalers while supplies last. Source: FDA website.
Voluntary Withdrawal05-20-10
Liposyn and Propofol
Hospira has announced a voluntary recall of certain lots of propofol and Liposyn due to containers that may have particulate matter. This is an expansion of a previous recall from March 31, 2010 and now includes additional lots distributed during a wider timeframe. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215033.htm Source: FDA website.
Drug Recall06-10-10
Ultram and Ultracet
The Food and Drug Administration (FDA) has announced changes to the Warnings section of the prescribing information for Ultram (tramadol) and Ultracet (tramadol/acetaminophen). The revisions are being done to emphasize the risk of suicide in individuals who are addiction-prone or using tranquilizers or antidepressants. Tramadol may have additive effects when used with alcohol or drugs that cause central nervous system depression. Overdosage could lead to central nervous system depression, respiratory depression, and death. Source: FDA website.
Drug Recall05-25-10
Lumizyme
The Food and Drug Administration (FDA) has approved Lumizyme (alglucosidase alfa for intravenous infusion) for the treatment of patients 8 years of age and older with late onset Pompe disease who do not have evidence of cardiac hypertrophy. Source: FDA website.
New Drug05-25-10
Proton Pump Inhibitors
The Food and Drug Administration (FDA) has announced revisions to the prescription and over-the counter (OTC) labels for proton pump inhibitors (PPIs) to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. The FDA is recommending that healthcare professionals consider whether a lower dose or shorter duration of therapy would be adequate when prescribing PPIs. Source: FDA website.
Drug Warning05-25-10
Xenical and Alli
The Food and Drug Administration (FDA) has announced revisions to the prescribing label for Xenical (orlistat 120 mg) to include new safety information with regards to rare cases of severe liver injury that have been reported with use of this medication. The FDA is also adding a new warning about these reports to the over-the-counter (OTC) Drug Facts label for Alli (orlistat 60 mg). Healthcare professionals should weigh the benefits versus potential risks associated with these products before prescribing or recommending them. Patients should stop use of these products and contact their healthcare professional if they begin having signs or symptoms of liver injury including itching, yellow eyes or skin, dark urine, light-colored stool, or loss of appetite. Source: FDA website.
Drug Warning05-26-10
Hylenex recombinant
Baxter International Inc has announced a precautionary voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection) due to reports of particulate matter seen in a limited number of vials during routine stability testing. A press release can be found on the FDA website at: http://www.fda.gov/Safety/Recalls/ucm213012.htm Source: FDA website.
Drug Recall05-26-10
Claris Intravenous Medications
The Food and Drug Administration (FDA) notified healthcare professionals not to use metronidazole, ciprofloxacin, and ondansetron intravenous medications manufacturered by Claris Lifesciences due to contamination. The products were sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Claris is initiating a recall of all lots of these products. See the following link for more details: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm214035.htm Source: FDA website.
Drug Recall06-01-10
Prolia
The Food and Drug Administration (FDA) has approved Prolia (denosumab subcutaneous injection) for the treatment of postmenopausal women with osteoporosis at high risk for fracture or individuals who have failed or are intolerant to other therapies for osteoporosis. Source: FDA website.
New Drug06-01-10
Benicar
The Food and Drug Administration has announced they are evaluating data from two clinical trials of Benicar (olmesartan), which is used to treat high blood pressure. Individuals taking Benicar had a higher rate of death from cardiovascular causes compared to those taking a placebo. The review is ongoing and the agency has not yet made any conclusions. The FDA states that the benefits of Benicar currently outweigh its potential risks. Source: FDA website.
Drug Warning06-11-10
Jevtana
The Food and Drug Administration (FDA) has approved Jevtana (cabazitaxel injection) to be used in combination with prednisone to treat men with prostate cancer. Source: FDA website.
New Drug06-17-10
Jalyn
The Food and Drug Administration (FDA) has approved Jalyn (dutasteride and tamsulosin) for the treatment of symptomatic benign hyperplasia (BPH) in men with an enlarged prostate. Source: FDA website.
New Drug06-16-10
GammaGard Liquid
The Food and Drug Administration (FDA) and Baxter BioScience has announced a voluntary market withdrawal of two lots of GammaGard Liquid (immune globulin intravenous, human) due to an increased number of adverse event reports of allergic reactions associated with these lots. The complete Market Withdrawal Notice can be found at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm214365.htm Source: FDA website
Voluntary Withdrawal06-04-10
Hydromorphone 2mg tablet - Lot Recall
ETHEX Corporation is announcing a voluntary recall affecting a single lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script E on one side and a 2 on the other side. If you have any questions related to this recall, please contact ETHEX Customer Service at 1-800-748-1472 or e-mail to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST. If you think you've experienced any adverse reactions to this drug, please contact your physician and/or healthcare provider immediately. Source: FDA Web Site
Drug Recall12-24-09
Epogen and Procrit
The Food and Drug Administration (FDA) and the manufacturer of Epogen (epoetin alfa) and Procrit (epoetin alfa) have announced that certain lots of medications are being recalled because the vials may contain extremely thin glass flakes. Serious adverse events could potentially occur as a result. View the following link for additional details: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm227225.htm Source: FDA website.
Drug Recall09-24-10
Generic Imitrex
The injectable, inhalation, and tablet formulations of Imitrex (also known as sumitriptan) are now available as a generic. Sumitriptan is approved for acute treatment of migraine headache in adults. This medication should only be used to treat a migraine headache that has already begun. It will not prevent headaches or reduce the number of migraine attacks. ARE GENERIC DRUGS AS EFFECTIVE AS BRAND-NAME DRUGS? Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. Every brand-name drug does not have a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 17 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it. Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA. Source: FDA web site
New Generic12-10-08
Hydromorphone and Metoprolol - Lot Recall
ETHEX Corporation, a subsidiary of KV Pharmaceutica, is issuing a nationwide voluntary recall of the products identified below (all lots within their expiration dates) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. If you have any of these medicines in your possession, consult with your doctor to see if you need to obtain replacement medications. You should not stop taking some of these medications abruptly as they may put you at risk for complications. *** Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11) *** Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11) *** Hydromorphone HCl Tablets, 8mg (58177-449-04) *** Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11) *** Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11) *** Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11) *** Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11) If you have any questions related to this recall, please contact ETHEX Customer Service at 1-800-748-1472 or 314-646-3788, or e-mailed to customer-service@ethex.com. Source: FDA web site
Drug Recall01-28-09
Mylotarg
The Food and Drug Administration (FDA) has notified healthcare professionals of the market withdrawal of Mylotarg (gemtuzumab ozogamicin), indicated for treatment of acute myeloid leukemia (AML), due to the results from a recent clinical trial that raised new safety concerns and failed to show a clinical benefit to enrolled subjects. Mylotarg will not be commercially available to initiate therapy in AML. Individuals who are currently receiving treatment with Mylotarg may complete their therapy and should be informed of the potential safety risks. Source: FDA website.
Drug Warning06-21-10
Namenda XR
New Drug06-21-10
Rapaflo
Rapaflo (silodosin) is a new drug available for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. BPH is a male disease where the prostate gland (located between the bladder), which stores urine, and the urethra, the tube through which urine exits the body; enlarges in men as they age. By age 50, roughly 50 percent of all men suffer from BPH. By age 80, that number jumps to 75 percent. When the prostate gland enlarges, it begins to press against the urethra. This pressure can impede the flow of urine and make it difficult to eliminate it from the body. In the early stages of BPH, the disease can also create a need to urinate more frequently, or cause dribbling after urination. BPH can also lead to an increased risk of urinary tract infections and urinary retention. Urinary retention can damage the kidneys and cause urinary tract infections by mixing urine from the ureter with urine from the bladder that is heavily laden with bacteria.Rapaflo works by blocking the alpha-1 adrenoreceptors in the prostate, bladder, and urethra. By blocking these receptors, Rapaflo allows the smooth muscle in these tissues to relax, resulting in a reduction in BPH symptoms. Rapaflo is not recommended for men who suffer from severe kidney or liver impairment and is not approved for pediatric use.It is important for patients to know and that cancer of the prostate gland and BPH cause many of the same symptoms and that these two diseases, BPH and prostate cancer, frequently co-exist. Therefore, patients thought to have BPH should be examined prior to starting therapy with Rapaflo to rule out the presence of prostate cancer. The most common side effect seen with Rapaflo is reduced or no semen during orgasm. This side effect does not pose a safety concern and is reversible with discontinuation of the product. Other side effects included dizziness, light-headedness, diarrhea, orthostatic hypotension (drop in blood pressure upon standing), headache, nasopharyngitis (a contagious viral infection of the nose and upper portion of the throat), and nasal congestion. Patients planning cataract surgery must notify their ophthalmologist that they are taking Rapaflo because of the possibility of a condition called Intraoperative Floppy Iris Syndrome (IFIS), a complication associated with cataract surgery in patients on alpha-1 adrenoreceptor blocker medications. In IFIS the iris of the eye becomes limp and moves in waves as a result of increases in fluid levels within the eye. This can result in a painful and extended recovery period in those who have undergone cataract surgery and a reduction in visual acuity (sharpness). Patients on alpha-blockers or those who have severe kidney or liver impairment should not use Rapaflo. Source: FDA Web Site
New Drug03-09-09
Tamiflu
The Food and Drug Administration (FDA) has notified healthcare professionals and consumers about a potentially harmful counterfeit product being sold over the internet. The product is represented as generic Tamiflu. FDA tests have shown that the active ingredient in this product is cloxacillin. Individuals who are allergic to penicillin products are at risk of similar reactions from cloxacillin. Source: FDA website.
Drug Warning06-18-10
Tasigna
The Food and Drug Administration (FDA) has approved Tasigna (nilotinib) for the expanded indication of first-line treatment of chronic myeloid leukemia. Source: FDA website.
New Indications06-17-10
Zencore Plus - Recall
Drug Recall03-20-09
Glassia
The Food and Drug Administration (FDA) has approved Glassia (alpha-1 antitrypsin injection) for the treatment of the genetic disorder alpha-1 antitrypsin deficiency (AATD). Source: FDA website.
New Drug07-02-10
Infergen
The Food and Drug Administration (FDA) has approved an expanded indication for Infergen (interferon alfacon-1 injection) to include use in combination with ribavirin for retreatment of chronic hepatitis C patients. Source: FDA website.
New Indications07-06-10
Zuplenz
The Food and Drug Administration (FDA) has approved Zuplenz (ondansetron oral soluble film) for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Source: FDA website.
New Drug07-05-10
Staxyn
The Food and Drug Administration (FDA) has approved Staxyn (vardenafil orally disintegrating tablets) for the treatment of erectile dysfunction. Source: FDA website.
New Drug06-18-10
Lucentis
The Food and Drug Administration (FDA) has approved Lucentis (ranibizumab) for the treatment of macular edema following retinal vein occlusion (RVO). Source: FDA website.
New Indications06-23-10
Dulera
The Food and Drug Administration (FDA) has approved Dulera (mometasone furoate and formoterol fumarate) inhalation aerosol for the treatment of asthma in individuals > 12 years of age. Source: FDA website.
New Drug06-24-10
Butrans
The Food and Drug Administration (FDA) has approved Butrans (buprenorphine transdermal system) for the management of moderate to severe chronic pain in individuals requiring a continuous, around-the-clock, opioid analgesic for an extended period of time. Source: FDA website
New Drug07-01-10
Daytrana
New Indications07-07-10
Qualaquin
The Food and Drug Administration (FDA) has approved a risk managment plan to warn against the use of Qualaquin (quinine sulfate) for the unapproved use of night time leg cramps. Qualaquin use may result in serious hematological reactions and it is only FDA approved for the treatment of malaria. Source: FDA website.
Drug Warning07-08-10
Tainted Weight Loss Products - Alert
Drug Warning03-24-09
Propafenone 225mg Tablet - Lot Recall
Watson Pharmaceuticals is announcing a recall affecting one lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States. The lot number affected by this recall is 112680A and has an expiration date of July 31, 2010. The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 08 and November 26, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients. Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled. Anyone with 225 mg Propafenone HCL tablets being recalled should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product. Source: FDA Web Site
Drug Recall03-25-09
Beyaz
The Food and Drug Administration (FDA) approved Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium), an oral contraceptive that contains folate to prevent neural tube defects. It is approved for prevention of pregnancy, premenstrual dysphoric disorder, and moderate acne. Source: FDA website.
New Drug09-24-10
All Lots of Caraco brand Digoxin Tablets
Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, is announcing a recall of all strengths Caraco brand Digoxin tablets (0.125 mg and USP, 0.25 mg) distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients. Any one with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase. Product Identification Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with "437" Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with "441" NDC Numbers: Digoxin Tablets, USP, 0.125 mg 57664-437-88 (100-count) 57664-437-18 (1000-count) Digoxin Tablets, USP, 0.25 mg 57664-441-88 (100-count) 57664-441-18 (1000-count) Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance. Source: FDA Web Site
Drug Recall04-01-09
Angiotensin Receptor Blockers
The Food and Drug Administration (FDA) is conducting an ongoing safety review to evaluate cancer risk in individuals taking angiotensin receptor blockers (ARBs) for high blood pressure and other conditions. Recent clinical study findings suggested use of ARBs may be associated with a small increased risk for cancer. The FDA is reviewing the data and has not made a conclusion. Source: FDA website
Drug Warning07-15-10
Raptiva
Genentech, Inc. is announcing that it will start a phased voluntary withdrawal of the psoriasis drug Raptiva (generic name: efalizumab) from the U.S. market. Genentech's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. Physicians have been asked not to write prescriptions for Raptiva for any new patients and should be contacting their patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking Raptiva, enough time to work with their doctors to appropriately discontinue use of Raptiva. Abrupt discontinuation of Raptiva may worsen your psoriasis. If you are on Raptiva, talk to your physician before stopping treatment. Source: FDA Website
Voluntary Withdrawal04-08-09
Advair Diskus
Advair Diskus (fluticasone propionate and salmeterol) inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. Safety and effectiveness cannot be assured and these inhalers should not be used. The affected lot numbers and additional details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219416 Source: FDA website.
Drug Warning07-16-10
Arava
The Food and Drug Administration (FDA) is adding information on the risk of severe liver injury to the Boxed Warning of Arava (leflunomide). This revision to the prescribing information is based on the FDA's review of reports of severe liver injury, including cases of fatal liver failure, in individuals receiving Arava. Source: FDA website
Drug Warning07-13-10
Veltin
The Food and Drug Administration (FDA) has approved Veltin (clindamycin phosphate/tretinoin) gel for the topical treatment of acne vulgaris in individuals 12 years and older. Source: FDA website.
New Drug07-16-10
Cuvposa
The Food and Drug Administration (FDA) has approved Cuvposa (glycopyrrolate liquid) for chronic severe drooling caused by neurologic disorders in children aged 3 to 16 years. Source: FDA website.
New Drug07-29-10
Cubicin
The Food and Drug Administration (FDA) has communicated about the risk for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin injection). Symptoms include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to respiratory failure and is potentially fatal if not properly managed. Patients receiving Cubicin should immediately contact their healthcare professional if they experience any of the above symptoms. Source: FDA website.
Drug Warning07-29-10
Tribenzor
The Food and Drug Administration (FDA) has approved Tribenzor (olmesartan, amlodipine, and hydrochlorothiazide tablets) for the once daily treatment of hypertension in individuals who are not adequately controlled on any two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics. Source: FDA website.
New Drug07-26-10
Evamist
The Food and Drug Administration (FDA) has announced that it is reviewing reports of adverse events caused by Evamist (estradiol transdermal spray). Unintentional exposure to children through skin contact may cause premature puberty. Individuals using Evamist should make certain that children do not come into contact with any skin area where the drug has been applied. Source: FDA website.
Drug Warning07-29-10
Xeomin
The Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA) for the treatment of adults with cervical dystonia or blepharospasm. Source: FDA website.
New Drug08-02-10
NeoProfen
The Food and Drug Administration (FDA) has announced a recall of two lots of NeoProfen (ibuprofen lysine) injection due to the risk of particulate matter. The recall includes lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012). Source: FDA website.
Drug Recall08-02-10
Nimodipine
The Food and Drug Administration (FDA) has reminded healthcare professionals that oral nimodipine capsules should only be given by mouth or through a feeding or nasogastric tube and should never be administered intravenously. Intravenous administration may result in death, cardiac arrest, severe drops in blood pressure, and other complications. Source: FDA website
Drug Warning08-02-10
Afluria
The Food and Drug Administration (FDA) has updated the Warnings and Precautions sections of the Prescribing Information for Afluria influenza virus vaccine to include information on reports of fever and febrile seizure in young children in Australia. Available data suggests that the inceased risk of fever and febrile seizure are only associated with the Southern Hemisphere formulation of the Afluria vaccine. Investigations are still ongoing. Source: FDA website.
Drug Warning08-02-10
Valcyte
The Food and Drug Administration (FDA) has approved Valcyte (valganciclovir) for an increased length of therapy in adult kidney transplant patients at high risk of cytomegalovirus (CMV) disease. Source: FDA website
New Indications08-10-10
Influend Cough and Cold Products in Alabama
ION Labs Inc. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products due to the products not tested in conformance with the specifications of the lab, therefore the products may have a possibility to be super potent. Possible complications may include Tachycardia (fast heart rate), palpitations, arrhythmias, cardiovascular collapse with hypotension, headaches, dizziness, anxiety, restlessness and nervousness. The following products were distributed and sold directly to consumers in the Madison/Huntsville, Alabama area: ** Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074 ** Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075 ** Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076 ** Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077 ** Although no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice. If you have this product in your possession, stop using it immediately and contact your physician if you think you have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below. ION Labs, Inc., 115th Ave. N., Clearwater, Fl. 33760 If you have any questions about the above recall, please contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT. Source: FDA Web Site
Drug Recall04-16-09
Dietary Supplements by Universal ABC Beauty Supply
Lab analyses performed by the Food and Drug Administration (FDA) on samples of dietary supplements distributed by Universal ABC Beauty Supply International, Inc contained undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Dietary supplements are not supposed to contain Sibutramine. The FDA has not approved these products, therefore the safety and effectiveness of these products is unknown. FDA advises that these products pose a threat because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. NOTE: The products below may have various UPC numbers. All lots of the following dietary supplement products are being recalled: Product Names: *** ProSlim Plus, 60 capsules, bottle in box *** 3 DAYS fit, 60 capsules, bottle in box *** EIGHT FACTOR DIET, 60 capsules, 3 pouches/box *** 24hours Diet, 60 capsules *** Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box *** 3X SLIMMING POWER, 60 capsules, bottle in box *** Extrim Plus 24 Hours RE-BURN Formula, 60 capsules *** Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box *** Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box *** SLIM EXPRESS 360 (degree sign) C *** SLIM EXPRESS 4in1, 60 capsules, bottle in box *** ROYAL SLIMMING FORMULA, 60 capsules, bottle/box *** BODY CREATOR, 90 capsules, 3 pouches/box *** Slim Waistline (labeling written in Chinese) *** BODY SHAPING, 90 capsules, 3 pouches/box *** PERFECT SLIM, 90 capsules, 3 pouches/box *** Perfect Slim 100 Percent Natural Herbal Essence *** IMELDA Perfect Slim *** Slim Waist Formula, 32 capsules, 2 pouches/box *** Super Slimming, 60 capsules, bottle in box *** 2 DAY DIET *** Powerful Slim *** BODY SHAPING *** SUPER FAT BURNER, 60 capsules, bottle in box *** SLIMMING FORMULA *** SLIM FAST 2, 32 capsules, 2 pouches/box *** SLIM FAST, 60 capsules, 3 pouches/box *** Slim up, 120 capsules, bottle in box *** 7 DAYS DIET, 60 capsules, 3 pouches/box *** Perfect Slim Up, 60 capsules, bottle in box ** JM Fat Reducer *** SlimBurn ** 21 Double SLIM *** TRIM PLUS 2 The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers. Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion. If you have questions for Universal ABC Beauty Supply International, you should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00 pm through 6 pm, EDT. Source: FDA Web Site
Drug Recall04-22-09
Lastacaft
The Food and Drug Administration (FDA) has approved Lastacaft (alcaftadine ophthalmic solution) for the prevention of itching associated with allergic conjunctivitis in patients over 2 years of age. Source: FDA website
New Drug07-28-10
Xyntha
The Food and Drug Administration (FDA) has approved a pre-filled, dual-chamber syringe for administration of Xyntha (antihemophilic factor, recombinant) for hemophilia A treatment. Source: FDA website.
New Drug08-10-10
Ella
The Food and Drug Administration (FDA) has approved Ella (ulipristal acetate tablet) for the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Source: FDA website.
New Drug08-13-10
Hydroxycut - Dietary Supplement Recall
The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. The FDA urges consumers to discontinue using Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes: Hydroxycut Regular Rapid Release Caplets Hydroxycut Caffeine-Free Rapid Release Caplets Hydroxycut Hardcore Liquid Caplets Hydroxycut Max Liquid Caplets Hydroxycut Regular Drink Packets Hydroxycut Caffeine-Free Drink Packets Hydroxycut Hardcore Drink Packets (Ignition Stix) Hydroxycut Max Drink Packets Hydroxycut Liquid Shots Hydroxycut Hardcore RTDs (Ready-to-Drink) Hydroxycut Max Aqua Shed Hydroxycut 24 Hydroxycut Carb Control Hydroxycut Natural Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts. Source: FDA Web Site
Drug Recall05-01-09
Midodrine
The Food and Drug Administration (FDA) has announced a proposal to withdraw approval of midodrine hydrochloride which is used to treat low blood pressure. This proposal was made because post-approval studies to verify the clinical benefit of the drug have not been done for the brand name ProAmatine or generic versions of this drug. Patients who currently take midodrine should not stop taking it and should consult their health care professional about alternative treatments. Source: FDA website.
Drug Warning08-16-10
Lamictal
Drug Warning08-12-10
Accu-Chek Spirit Insulin Pumps - Lot Recall
Disetronic Medical Systems Inc. is notifying its customers, distributors and healthcare professionals about a potential defect in the up and/or down buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the up and/or down buttons. The pump’s up and down buttons are used for changing the program in the menu or to administer additional insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. This defect was discovered through the company’s normal quality control monitoring process. The pumps in question have serial numbers in the range from SN02119552 through SN10006093. If the vibration or acoustic confirmation signal does not occur, the user should disconnect the pump, and switch to a back up pump or an alternative method of insulin delivery. Immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for any other questions regarding this potential defect. Customers should expect the replacement pump within 1-2 business days after contacting ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. If you have any questions regarding this recall or questions pertaining to replacement, please contact ACCU-CHEK Spirit hotline at 1-800-778-5095 for further information. This number is available 24 hours a day, 7 days a week. Users of an ACCU-CHEK Spirit insulin pump, who are experiencing failure of the up and/or down buttons, should immediately contact ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week. Source: FDA Web Site
Drug Recall05-01-09
Antiseizure Medication - Drug Warning
The Food and Drug Administration (FDA) has approved updated labeling information for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). The FDA is requiring that manufacturers of these products develop a medication guide to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, the FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication. Source: FDA Web Site
Drug Warning05-04-09
Octagam
The Food and Drug Administration (FDA) and the manufacturer of Octagam (immune globulin intravenous human 5% liquid preparation) announced that, effective immediately, there is a voluntary market withdrawal of all lots of Octagam due to previously reported thromboembolic events. View the following link for additional details: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223968.htm Source: FDA website.
Voluntary Withdrawal09-24-10
Caraco brand Digoxin Tablets 0.25mg - Drug Recall
A S Medication Solutions, LLC, a drug repackage company, has announced that it is conducting a nationwide recall of all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients. Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase. Product Identification **** Caraco Digoxin A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with "441 NDC Numbers: Digoxin Tablets, USP, 0.25 mg 54569-5758-0 (30-count) Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance. Source: FDA Web Site
Drug Recall05-12-09
Zicam Nasal Products
The U.S. Food and Drug Administration is advising consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. The products are: --Zicam Cold Remedy Nasal Gel --Zicam Cold Remedy Nasal Swabs --Zicam Cold Remedy Swabs, Kids Size (a discontinued product) The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment. The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval. Consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone. --Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm --Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: 800-FDA-0178 --Phone: 800-FDA-1088 Source: FDA Web Site
Drug Warning06-22-09
Levimir Insulin
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots. The agency is advising patients who use Levemir insulin to: 1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial. 2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing. 3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution. 4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions. Source: FDA Web Site
Drug Warning06-22-09
Stamina Dietary Supplement
Hi-Tech Pharmaceuticals, Inc., has announced that it is conducting a nationwide voluntary recall of the company' product sold under the name Stamina-Rx. On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient ? benzamidenafil ? a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs. In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media. Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST. The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm or by phone at 1-800-FDA-1088. Source: FDA Web Site
Drug Recall06-22-09
Lantus - Early Communication
The FDA is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients SHOULD NOT stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. Patients should also contact their healthcare professional if they have concerns about the medicines they are taking. Similar to human insulin, insulin glargine is used to control blood sugar in people with Type 1 and Type 2 diabetes. Insulin glargine, however, is a modified version of human insulin (an insulin analogue) that allows for the control of blood sugar for extended periods of time (a long-acting insulin). Insulin glargine is approved for once-a-day dosage by subcutaneous injection (injection under the skin). The four observational studies evaluated large patient databases and all reported some level of association between the use of insulin glargine, and other insulin products, and various types of cancer. The duration of patient follow-up in all four studies was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure. Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk. FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. The FDA will communicate its findings with the public as soon as its review of insulin glargine is complete. The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program using the information below. *** Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm *** Phone: 1-800-332-1088 *** Fax: 1-800-FDA-0178 *** Regular Mail: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 *** FDA Form 3500 is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf Source: FDA Web Site
Drug Warning07-01-09
Stalevo
The Food and Drug Administration (FDA) has stated that it is evaluating data from a Stalevo (entacapone/carbidopa/levodopa) clinical trial that suggests that patients taking Stalevo may have a greater risk for developing prostate cancer. The FDA is still reviewing all information that is available and has not yet made a conclusion on the possible risk. Source: FDA website.
Drug Warning03-31-10
Tekamlo
The Food and Drug Administration (FDA) has approved Tekamlo (amlodipine/aliskiren) for the treeatment of high blood pressure. Source: FDA website.
New Drug08-27-10
Suboxone
The Food and Drug Administration (FDA) has approved Suboxone (buprenorphine/naloxone) sublingual film for maintenance treatment of opioid dependence in conjunction with counseling and psychosocial support. Source: FDA website
New Drug08-31-10
Chantix and Zyban
The FDA is notifying the public that the use of Chantix (varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions. The FDA is requiring the manufacturers of these products, including generic versions of Zyban (bupropion), to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information. People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away. Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away. Although Chantix and Zyban are effective aids in helping people stop smoking, they have been associated with serious adverse effects. Some people who have taken Chantix or Zyban to help them quit smoking have reported experiencing unusual behavior changes, have become depressed or have had their depression worsen, or have had thoughts about suicide or dying; some have attempted suicide either while using one of these drugs or after they stopped taking them. Since Chantix and Zyban do not contain nicotine, people who decide to use these drugs to help them stop smoking may still experience symptoms of nicotine withdrawal. It is common for people who are attempting to break their nicotine habit to experience unpleasant symptoms like depressed mood, irritability, restlessness, feeling anxious and trouble sleeping. Smoking is known to cause serious and potentially fatal health consequences, including lung cancer and other cancers, heart attacks, stroke, emphysema, and other breathing/lung diseases. The risks that are known to be associated with smoking must be balanced against the small, but real risk of serious adverse effects associated with medicines that can help patients quit smoking when making the decision on whether to use a medicine and/or other method to help stop smoking. In addition to the new Boxed Warning, FDA is also requiring the manufacturers of Chantix, Zyban, and generic versions of Zyban to provide Medication Guides for these products. Source: FDA Web Site
Drug Warning07-01-09
Tygacil
The Food and Drug Administration (FDA) has reminded healthcare professionals of an increased mortality risk associated with the use of Tygacil (tigecycline), an intravenous antibacterial agent, compared with other drugs used to treat serious infections. The FDA has updated sections of the prescribing information. Alternative treatments should be considered in individuals with severe infections. Source: FDA website.
Drug Warning09-01-10
Saphris
The Food and Drug Administration (FDA) has approved expanded indications for Saphris (asenapine) to include maintenance treatment of schizophrenia in adults and adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with biolar I disorder in adults. Source: FDA website.
New Indications09-07-10
Valcyte
The Food and Drug Administration (FDA) has notified healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir) oral tablets and solution. This revision will help prevent the potential for Valcyte overdosing in children with low body weight, low body surface area, and below normal serum creatinine. Source: FDA website.
Drug Warning09-15-10
Stealth Chocolate and Vanilla Suppl. - Lot Recall
Vital Pharmaceuticals Inc. is recalling 17 lots of the powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. ********************************************* Vanilla lot numbers affected: SP9118A2, SP9119B2, SP9120A2, SP9120B2, SP9121A2, SP9121B2, SP9131A2, SP9140A2, and SP9125A3. ****** Chocolate lot numbers affected: SP9118B2, SP9119A2, SP9121C2, SP9124A2, SP9124B2, SP127A2, SP127B2, SP9126A3. Stealth Vanilla and Stealth Chocolate dietary supplements were distributed Nationwide, including GNC Distribution Centers in Phoenix AZ; in Anderson, SC; and in Leetsdale, PA; and to VPX Sports Distribution Center in Weston, Fl; as well as Internationally. The powdered product is packaged in 5lb blue, plastic jars with red band on around the top and bottom of the jar. The principal label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer and the flavor in the lower 1/3; Vanilla Blast or Chocolate Rush. The production code and the expiration date are imprinted on the side panel above the Supplement Facts. The powdered product was also packaged in foil pouches as samples. No illnesses have been reported to date. But the company is taking this action because its product contains an ingredient Milk Protein Concentrate that was recalled by one of its supplier, Plainview Milk Products Cooperative, because it may be contaminated with Salmonella. If you have this product, please return it to the store where it was purchased for a full refund. If you have any questions, you may contact Vital Pharmaceutical Inc. at 1-800-954-7904 or 954-641-0570 during the hours of 9 am - 5 pm, Monday through Friday. ** Source: FDA Website
Drug Recall07-10-09
Libipower Plus Dietary Supplement - Recall
Haloteco is announcing a nationwide voluntary recall of their company's product sold under the name Libipower Plus. Lab analysis performed by the Food and Drug Administration (FDA) found that the product contained Tadalalafil which is the active ingredient of FDA approved drugs for Erectile Dysfunction (ED). The product label does not states it contain tadalafil. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. Libipower Plus is sold as a 1 capsule blister pack through distributors and retail stores in California. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Consumers with questions may contact Haloteco Monday through Friday 8:00 am to 5:00 pm at (213) 820-9523. Source: FDA Web Site
Drug Recall07-17-09
All Lots of Concentrated Acetaminophen Drops Recall
Brookstone Pharmaceuticals is issuing a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Brookstone has distributed 344 bottles nationally and has donated 5301 bottles to charity for international distribution. Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. The Food and Drug Administration (FDA) is aware of several medication error reports that document life-threatening or fatal adverse events in children less than three years of age, due to confusion associated with the concentrated versus regular strength acetaminophen liquid. Also, in a recent FDA advisory panel, it was recommended that one of the two strengths of acetaminophen should be removed from the market due to possible confusion which could result in overdosing. Brookstone's concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL. Regular strength acetaminophen elixir contains 160 mg/5 ml. The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. Brookstone Pharmaceuticals has notified customers that it has voluntarily stopped manufacturing and shipping Concentrated Acetaminophen Drops in bulk containers and has also advised customers (wholesalers and hospitals) to quarantine and hold the product for return to Brookstone Pharmaceuticals for a full refund. Customers with questions about the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802, option 2. Brookstone has not received any adverse events associated with this product but due to recent advisory panel concerns, Brookstone has taken voluntary action. Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Source: FDA Web Site.
Drug Recall07-16-09
Krystexxa
The Food and Drug Administration (FDA) has approved Krystexxa (pegloticase injection) for the treatment of chronic gout in adults refractory to conventional therapy. Source: FDA website.
New Drug09-15-10
Actos
The Food and Drug Administration (FDA) has announced an ongoing safety review to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. They are reviewing data from an ongoing 10 year clinical trial. The FDA has not yet made any conclusions. Individuals should continue taking Actos unless told otherwise by their healthcare professional. Source: FDA website
Drug Warning09-17-10
Gilenya
The Food and Drug Administration (FDA) has approved Gilenya (fingolimod) oral therapy for the treatment of relapsing multiple sclerosis (MS). Source: FDA website.
New Drug09-22-10
Octagam
Octapharma USA Inc. has announced a voluntary market withdrawal of certain lots of Octagam [immune globulin intravenous (human) 5% liquid] due to an increased number of reports of thromboembolic events. See the following link for more details: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm223897.htm . Source: FDA website.
Voluntary Withdrawal08-25-10
Six Male Enhancement Dietary Supplements - Recall
Nature & Health Co., is conducting a voluntary nationwide recall of their company's supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. Lab analysis conducted by the Food and Drug Administration (FDA) on these samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. The six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio. *** LibieXtreme was found to contain Aminotadafil *** Y-4ever was found to contain Sulfoaidenafil *** Libimax X Liquid contained Aminotadafil *** Powermania liquid contained Sulfoaidenafil *** Herbal Disiac contained Tadalafil *** Powermania contained Sulfoaidenafil. Customers who have these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Consumers should return any unused products, for a refund of the full purchase price or price for the unused portion, to the retail location where they were purchased or contact Nature & Health directly at (714) 671-0016Monday Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.
Drug Recall
Avandia
The Food and Drug Administration (FDA) has announced that it will significantly restrict the use of diabetes drug Avandia (rosiglitazone) to individuals with type 2 diabetes who cannot control their diabetes with other medications. These restrictions are due to recent data suggesting an increased risk of cardiovascular events in individuals treated with Avandia. The FDA is requiring that the manufacturer develop a restricted access program. New users will only be able to receive Avandia if they are unable to control their diabetes on other medications and are unable to take Actos (pioglitazone), which is the other drug in this class. Individuals who are currently using Avandia with positive results will be able to continue use if they choose to do so. Source: FDA website.
Drug Warning09-23-10
Kapvay
The Food and Drug Administration (FDA) approved Kapvay (clonidine extended-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents ages 6-17 years old. Kapvay is approved for use as monotherapy or for use as add-on therapy to stimulant medication. Source: FDA website
New Drug10-04-10
Young You Corporation Recall of Weight Loss Pills
Lab analysis conducted by the Food and Drug Administration (FDA) on four weight loss dietary supplements manufactured by Young You were found to contain an undeclared drug: sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled: *** Slimbionic, One Weight Loss Pill 30 capsules, SlimDemand Capsules, and Bontanical Weight Loss. The above listed products were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, CA. The FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers are advised to destroy the above products or return them to the company’s address in Tarzana, CA. Consumers with questions may contact Young You Corp Monday through Friday 9:00 am to 5:30 pm at 818-344-3344. Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm. Source: FDA Web Site
Drug Recall07-19-09
Meridia
The Food and Drug Administration (FDA) and Abbott Laboratories have notified healthcare professionals and patients of the voluntary withdrawal of Meridia, a drug for the treatment of obesity, from the United States market due to data indicating an increased risk of heart attack and stroke. Physicians are advised to stop prescribing Meridia and consumers should discontinue use of this medication. Source: FDA website.
Voluntary Withdrawal10-08-10
Lipitor 40 mg
Pfizer has recalled specific bottles of Lipitor (atorvastatin) 40 mg due to a small number of reports of an uncharacteristic odor related to the packaging. It has been determined that the odor is not likely to cause adverse health effects in individuals taking the product. The entire safety summary can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229006.htm
Drug Recall10-10-10
Atelvia
The Food and Drug Administration (FDA) has announced the approval of Atelvia (risedronate sodium delayed-release tablets) for the treatment of postmenopausal osteoporosis. Source: FDA website.
New Drug10-11-10
Vivitrol
The Food and Drug Administration (FDA) has stated there will be an update to the prescribing information for Vivitrol (naltrexone injection) regarding the risk of injection site reactions based on postmarketing reports received prior to June 2009. The agency requires that a Medication Guide be provided and that all patients understand these risks. Source: FDA website.
New Indications05-04-10
Body Building Supplements - Warning
The Food and Drug Administration (FDA) is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include " TREN-Xtreme," "MASS Xtreme," "ESTRO Xtreme," "AH-89-Xtreme," "MMA-3 Xtreme," "VNS-9 Xtreme," and "TT-40-Xtreme." The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness. Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA also recommends that consumers talk with their health care professional about any body building supplements they are taking or planning to take, particularly if they are uncertain about a product's ingredients. Source: FDA Web Site
Drug Warning07-28-09
Steam Dietary Supplement
Steam, a dietary supplement manufactured by Nutracoastal Trading LLC, is being recalled due to lab analysis conducted by the Food and Drug Administration (FDA) that found the product contains sulfoaildenafil. Sulfoaildenafil an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Steam an unapproved drug. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing. The recalled product was distributed in white plastic bottles to retail stores nationwide. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Source: FDA Web Site
Drug Recall07-29-09
Dextroamphetamine/Amphetamine 20mg Tab Lot Recall
Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite. This product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately. Consumers with questions may contact 888-742-5578 from 8:00am - 8:00pm EDT Monday-Friday. Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm. Source: FDA Web Site
Drug Recall09-28-09
Onglyza
The Food and Drug Administration (FDA) has approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels. Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal. The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives. Source: FDA Web Site
New Drug08-31-09
Sitagliptin and Sitagliptin/Metormin: Drug Warning
The Food and Drug Admdinitration (FDA) is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Between October 16, 2006 and February 9, 2009, there have been 88 reported cases of acute pancreatitis; including two cases of hemorrhagic or necrotizing pancreatitis. If you are currently using sitagliptin or sitagliptin/metformin, ** Be aware that acute pancreatitis has been reported in patients using these products ** Pay close attention for any signs or symptoms of pancreatitis such as nausea, vomiting, anorexia, and persistent severe abdominal pain, sometimes radiating to the back. ** Promptly discuss any signs and symptoms of pancreatitis with a healthcare professional. ** Do not stop or change medicines that have been prescribed without first talking with a knowledgeable healthcare professional. Source: FDA Web Site
Drug Warning09-25-09
Bisphosphonates
The Food and Drug Administration (FDA) announced a labeling change regarding the risk of atypical fractures of the thigh in individuals taking bisphosphonates for osteoporosis. The Warnings and Precautions section of the labels of all bisphosphonate medications that are indicated for osteoporosis and their generic equivalents will be revised. In addition, all individuals prescribed a bisphosphonate will be given a Medication Guide. Patients should continue to take their medications unless told otherwise by their healthcare professional. The FDA is currently recommending that antiresorptive medications, including bisphosphonates, should be discontinued in individuals who have evidence of a femoral shaft fracture. The FDA will continue their ongoing review of this issue including an evaluation of the safety of long term use of these medications. Source: FDA website.
Drug Warning10-13-10
Gamunex-C
The Food and Drug Administration (FDA) approved Gamunex-C (immune globulin injection) for subcutaneous administration in the treatment of primary immunodeficiency (PI). Source: FDA website.
New Drug10-14-10
H.P. Acthar Gel
The Food and Drug Administration (FDA) approved H.P. Acthar Gel (repository corticotropin injection) for the treatment of infantile spasms. Source: FDA website.
New Indications10-15-10
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa (dabigatran etexilate capsules) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Source: FDA website.
New Drug10-20-10
Invirase
The Food and Drug Administration (FDA) notified healthcare professionals of new risk information added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the labeling for Invirase. The updated labeling describes the potential risk of abnormal heart rhythms in individuals taking this drug in combination with ritonavir. A Medication Guide will also be required when individuals are picking up a prescription for Invirase. Source: FDA website
Drug Warning10-21-10
Fentanyl transdermal system
The Food and Drug Administration (FDA) notified healthcare professionals and consumers that laboratory testing has identified a fentanyl transdermal patch that released its active ingredient faster than approved specifications. The product is manufactured for Actavis by Corium International. A link to the press release with details on the recall can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230639.htm Source: FDA website.
Drug Recall10-22-10
Herceptin
The Food and Drug Administration (FDA) approved Herceptin (trastuzumab injection) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil) for HER2-positive metastatic stomach cancer in individuals who have not received prior treatment for their metastatic disease. Source: FDA website
New Indications10-21-10
Lo Loestrin FE
The Food and Drug Administration (FDA) approved Lo Loestrin FE, an oral contraceptive containing norethindrone acetate, ethinyl estradiol, and ferrous fumarate for the prevention of pregnancy. Source: FDA website.
New Drug10-22-10
Botox
The Food and Drug Administration (FDA) approved Botox (onabotulinumtoxinA injection) for the prophylactic treatment of headaches in adults with chronic migraine. Source: FDA website
New Indications10-18-10
Bromday
The Food and Drug Administration (FDA) approved Bromday (bromfenac ophthalmic solution) as once daily treatment for postoperative inflammation and reduction of ocular pain in individuals who have undergone cataract extraction. Source: FDA website.
New Drug10-18-10
GnRh agonists
The Food and Drug Administration (FDA) notified healthcare professionals of new safety information added to the Warnings and Precautions section of the drug labels for GnRH agonists. The new labeling will warn about an increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, and stroke) in men receiving these medications for the treatment of prostate cancer. Healthcare professionals should evaluate the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer. Source: FDA website.
Drug Warning10-21-10
Baraclude
The Food and Drug Administration (FDA) approved Baraclude (entecavir tablets) for the treatment of chronic hepatitis B in adults with decompensated liver disease. Source: FDA website
New Indications10-18-10
Garamycin
The Food and Drug Administration (FDA) approved Garamycin (gentamicin sulfate ophthalmic ointment) preservative-free formulation for the treatment of susceptible ocular bacterial infections. FDA website.
New Drug10-18-10
Sprycel
The Food and Drug Administration (FDA) approved Sprycel (dasatinib) for the first-line treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukemia. FDA website.
New Indications10-28-10
Latuda
The Food and Drug Administration (FDA) approved Latuda (lurasidone tablets) for the treatment of adults with schizophrenia. FDA website.
New Drug10-28-10
Methotrexate
The Food and Drug Administration (FDA) has announced a recall of Methotrexate Injection, 50 mg/2 mL and 250 mg/10 mL vials, due to small glass flakes detected in a limited number of vials in four lots. Additional details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm231614.htm Source: FDA website.
Drug Recall10-29-10
Ofirmev
The Food and Drug Administration (FDA) has approved Ofirmev (acetaminophen injection) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. Source: FDA website
New Drug11-02-10
Afinitor
The Food and Drug Administration (FDA) has approved Afinitor (everolimus tablets) for subependymal giant cell astrocytoma associated with tuberous sclerosis. Source: FDA website.
New Indications11-01-10
Nuedexta
The Food and Drug Administration (FDA) has approved Nuedexta (dextromethorphan/quinidine) for the treatment of pseudobulbar affect. Source: FDA website.
New Drug10-29-10
Teflaro
The Food and Drug Administration (FDA) has approved Teflaro (ceftaroline fosamil) for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection caused by susceptible strains of indicated pathogens. Source: FDA website.
New Drug11-01-10
Heparin Sodium
The Food and Drug Administration (FDA) and B. Braun Medical Inc notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) due to a trace contaminant. A link to the press release can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm231739.htm Source: FDA website.
Drug Recall10-29-10
Cymbalta
The Food and Drug Administration (FDA) has approved Cymbalta (duloxetine) for the treatment of chronic musculoskeletal pain including low back pain and osteoarthritis. Source: FDA website.
New Indications11-05-10
Kombiglyze XR
The Food and Drug Administration (FDA) has approved Kombiglyze XR (saxagliptin/metformin extended release tablets) for the treatment of type 2 diabetes mellitus in adults. Source: FDA website.
New Drug11-05-10
Egrifta
The Food and Drug Administration (FDA) has approved Egrifta (tesamorelin injection) for the treatment of human immunodeficiency virus (HIV)-associated lipodystrophy. Source: FDA website.
New Drug11-10-10
Vyvanse
The Food and Drug Administration (FDA) has approved Vyvanse (lidexamfetamine dimesylate capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents 13-17 years of age. Source: FDA website
New Indications11-15-10
Halaven
The Food and Drug Administration (FDA) has approved Halaven (eribulin mesylate injection) for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. Source: FDA website.
New Drug11-15-10
Gablofen
The Food and Drug Administration (FDA) has approved Gablofen (baclofen for intrathecal injection) for the management of severe spasticity. Source: FDA website.
New Drug11-23-10
Axiron
The Food and Drug Administration (FDA) has approved Axiron (testosterone topical solution) for replacement therapy in men > 18 years of age for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website.
New Drug11-24-10
Tessalon
The Food and Drug Administration (FDA) has issued a warning that accidental ingestion of Tessalon and the generic benzonatate by children under the age of 10 years can result in death. There have been reports in children less than 2 years of age of overdose after accidental ingestion of as few as 1 or 2 capsules. Patients taking this medication should keep in a child-resistant container out of reach of children. If a child accidentally ingests this medication, seek medical attention immediately. Source: FDA website.
Drug Warning12-14-10
Avastin
The Food and Drug Administration (FDA) has announced that it is recommending removal of the breast cancer indication for Avastin (bevacizumab) from the label. This recommendation does not affect the other FDA approved indications for colon, kidney, brain, and lung cancers. The agency reviewed the clinical data available for Avastin in breast cancer treatment and determined that the drug does not prolong overall survival or provide sufficient benefit in slowing disease progression. In addition, subjects administered Avastin experienced significantly more serious adverse events. The FDA is recommending that oncologists use medical judgment when deciding whether to continue therapy with Avastin for breast cancer. Patients currently receiving Avastin for breast cancer should speak with their oncologists. Source: FDA website.
Drug Warning12-16-10
Anzemet
The Food and Drug Administration (FDA) has announced that a contraindication is being added to the prescribing information of Anzemet injection advising the product should no longer be used to prevent nausea and vomiting associated with chemotherapy in pediatrics and adults. New data shows an increased risk of developing abnormal heart rhythms when using this medication. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting because of the lower doses used in this indication. Anzemet tablets may still be used to prevent chemotherapy induced nausea and vomiting because the risk is lower with the oral dosage form. However, a stronger warning will be added to the label of the oral formulation. Source: FDA website.
Drug Warning12-17-10
Safyral
The Food and Drug Administration (FDA) has approved Safyral (drospirenone/ethinyl estradiol/levomefolate calcium) as an oral contraceptive that raises folate levels in women who want to use an oral contraceptive for birth control. Source: FDA website.
New Drug12-17-10
Abbott glucose test strips
The Food and Drug Administration (FDA) and Abbott Diabetes Care announced a recall of 359 different lots of glucose test strips marketed under various brand names due to the risk of false low blood glucose results. Details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237910.htm Source: FDA website.
Drug Recall12-22-10
Recombinant human growth hormone
The Food and Drug Administration (FDA) has announced that results from a study conducted in France found that persons with certain types of short stature treated with recombinant human growth hormone during childhood were at a small increased risk of death compared with others in the general population. The FDA is reviewing all available data and at this time believes the benefits of treatment outweigh any potential risks. Do not stop taking recombinant human growth hormone without talking to your healthcare professional. Source: FDA website.
Drug Warning12-22-10
Dexamethasone sodium phosphate
The Food and Drug Administration (FDA) and American Regent announced a recall of specific lots of dexamethasone sodium phosphate injection, USP 4 mg/mL, 30 mL multiple dose vials due to particulates in some vials. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238104.htm Source: FDA website.
Drug Recall12-24-10
Amturnide
The Food and Drug Administration (FDA) approved Amturnide (aliskiren/amlodipine/hydrochlorothiazide) tablet formulation for the treatment of hypertension. Source: FDA website.
New Drug12-23-10
Gardasil
The Food and Drug Administration (FDA) approved Gardasil (human papillomavirus vaccine) for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18 in males and females ages 9-26 years. Source: FDA website.
New Indications12-23-10
Fortesta
The Food and Drug Administration (FDA) approved Fortesta (testosterone topical gel) for the treatment of hypogonadism in men > 18 years of age. Source: FDA website.
New Drug12-29-10
Actemra
The Food and Drug Administration (FDA) approved Actemra (tocilizumab injection) for the inhibition and improvement of rheumatoid arthritis (RA) in adults with moderately to severely active RA when given in combination with methotrexate. Source: FDA website.
New Indications01-05-11
Chewable low dose contraceptive
The Food and Drug Administration (FDA) approved a chewable low dose oral contraceptive containing norethinedrone, ethinyl estradiol, and ferrous fumarate. A brand name has not been given at this time. Source: FDA website.
New Drug12-23-10
Lipitor 40 mg
Pfizer announced a recall of one lot of Lipitor 40 mg tablets distributed in the United States due to complaints of an uncharacteristic odor. Three similar recalls of Lipitor occurred earlier in 2010. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229006.htm Source: FDA website.
Drug Recall12-23-10
Sodium bicarbonate injection
The Food and Drug Administration (FDA) and American Regent announced a recall of specific lots of sodium bicarbonate injection, USP 7.5% and 8.4%, 50 mL single dose vials due to particulates in some vials. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238323.htm Source: FDA website.
Drug Recall12-29-10
Acetadote
Cumberland Pharmaceuticals announced a recall of 6 lots of Acetadote (acetylcysteine injection) in 30 mL single dose glass vials due to particulate matter found in certain vials. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238494.htm Source: FDA website.
Drug Recall01-01-11
Albuterol sulfate inhalation solution
The Ritedose Corporation is announcing a voluntary recall of albuterol sulfate 0.083% inhalation solution, 3 mL unit dose vials due to the 2.5 mg/3 mL single use vials being embossed with the wrong concentration. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238624.htm Source: FDA website.
Drug Recall01-03-11
Metronidazole 250 mg
The Food and Drug Administration (FDA) and Teva Pharmaceuticals are announcing a recall of metronidazole tablets 250mg (lot #312566, expiration date 05/2012) due to the presence of underweight tablets that may not contain the full amount of active ingredient. Details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239312.htm Source: FDA website.
Drug Recall01-06-11
Xgeva
The Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the prevention of skeletal-related events in individuals with bone metastases from solid tumors. Source: FDA website.
New Drug11-18-10
Propoxyphene
The Food and Drug Administration (FDA) has announced that Xanodyne Pharmaceuticals is withdrawing propoxyphene from the United States market at the request of the FDA. This is due to new data showing that propoxyphene can cause serious cardiac toxicity. The FDA has requested that the generic manufacturers of propoxyphene-containing products withdraw their products as well. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm Source: FDA website.
Voluntary Withdrawal11-19-10
Abstral
The Food and Drug Administration (FDA) approved Abstral (fentanyl transmucosal immediate release tablets) for the management of breakthrough pain in adults with cancer who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Source: FDA website.
New Drug01-10-11
Acetadote
The Food and Drug Administration (FDA) approved a new preservative-free formulation of Acetadote (acetylcysteine injection) that does not contain ethylene diamine tetracetic acid or any other stabilization and chelating agents. The new formulation also has a longer shelf life of 30 months and will replace the currently available formulation. Source: FDA website.
New Drug01-14-11
Morphine Sulfate oral solution
The Food and Drug Administration (FDA) and Roxane Laboratories announced reports of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the 100 mg/5 mL (20 mg/mL) product. Newly approved labeling and packaging feature revisions designed to reduce the risk of errors. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm Source: FDA website.
Drug Warning01-10-11
Acetaminophen prescription products
The Food and Drug Administration (FDA) announced that it has communicated to drug manufacturers that acetaminophen prescription products will be limited to 325 mg per dosage unit. The agency is taking this step to reduce the risk of liver injury and allergic reactions with acetaminophen. A Boxed Warning for severe liver injury and a Warning for allergic reactions will be added to the prescription labels for all products containing acetaminophen. Manufacturers have 3 years to implement this change, therefore no drug shortages are expected. Over the counter (OTC) products are not affected by this action. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239955.htm Source: FDA website.
Drug Warning01-13-11
Lantus
The Food and Drug Administration (FDA) announced that it has reviewed data and determined that the evidence has limitations and that it cannot be concluded that Lantus (insulin glargine) increases the risk of cancer. This possible risk had previously been communicated by the agency. The FDA's review is ongoing and they will provide updates when available. Patients should continue to take Lantus unless told otherwise by their healthcare professional. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm Source: FDA website.
Drug Warning01-12-11
Multaq
The Food and Drug Administration (FDA) announced that there is a risk of rare but severe liver injury including two cases of acute liver failure leading to liver transplant in individuals taking Multaq. This product is approved for use in the treatment of atrial fibrillation or atrial flutter and is contraindicated for use in NYHA Class II - IV heart failure. Individuals taking Multaq should be advised to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching). Information about the potential risk of liver injury is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information. Source: FDA website.
Drug Warning01-14-11
Natroba
The Food and Drug Administration (FDA) approved Natroba (spinosad topical suspension) for the treatment of head lice in individuals > 4 years old. Source: FDA website.
New Drug01-18-11
Viibryd
The Food and Drug Administration (FDA) approved Viibryd (vilazodone tablets) for the treatment of major depressive disorder in adults. Source: FDA website.
New Drug01-21-11
Rituxan
The Food and Drug Administration (FDA) approved Rituxan (rituximab) as first-line maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy. Source: FDA website.
New Indications01-31-11
Gralise
The Food and Drug Administration (FDA) approved Gralise (gabapentin delayed release tablets) for the once daily treatment of post-herpetic neuralgia (PHN). Source: FDA website.
New Drug01-31-11
Menveo
The Food and Drug Administration (FDA) approved Menveo (meningococcal vaccine) for use in children from 2 years of age and older. Source: FDA website.
New Indications 01-31-11
Makena
The Food and Drug Administration (FDA) approved Makena (hydroxyprogesterone caproate) for the prevention of preterm birth. Source: FDA website.
New Drug 02-04-11
American Regent Injectable Products
Recall of American Regent injectable products, including sodium thiosulfate injection 10% and potassium phosphates injection, due to the presence of visible particles in some vials. Please visit the following site for details: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm Source: FDA website.
Drug Recall 02-05-11
Hydrocodone/APAP and Phenobarbital
Recall of hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg due to an individual bottle found incorrectly labeled with phenobarbital tablets 32.4 mg label. Both products are manufactured by Qualitest Pharmaceuticals. Please visit the following site for details and specific lot numbers involved: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242527.htm Source: FDA website.
Drug Recall 02-07-11
Avandia
The Food and Drug Administration (FDA) announced that information on the cardiovascular risks associated with Avandia (rosiglitazone) has been added to the product labeling and the patient Medication Guide for all products containing rosiglitazone. Also, the drug labels will state that rosiglitazone should only be used in patients already being treated with this medication and in patients whose blood sugar cannot be controlled with other anti-diabetic medications. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm Source: FDA website.
Drug Warning 02-04-11
Terbutaline
The Food and Drug Administration (FDA) announced that injectable terbutaline should not be used for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in the hospital or outpatient setting due to the risk for maternal heart problems and death. Additionally, oral terbutaline should not be used for prevention or treatment of preterm labor. A Boxed Warning and Contraindication will be added to the product labeling. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm Source: FDA website.
Drug Warning 02-17-11
Warfarin
The Food and Drug Administration (FDA) and Upsher-Smith Laboratories have announced a recall of one lot of Jantoven Warfarin Sodium 3 mg tablets after a single bottle being labeled as 3 mg was found to contain a 10 mg strength. The recalled lot is numbered #284081 with an expiration date of September 2012. The recall was later expanded to include additional products that were packaged on the same packaging line during a specific time period. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243850.htm Source: FDA website.
Drug Recall 02-17-11
Corifact
The Food and Drug Administration (FDA) approved Corifact (factor XIII concentrate) to prevent bleeding in people with congenital Factor XIII deficiency. Source: FDA website.
New Drug 02-17-11
Abilify
The Food and Drug Administration (FDA) approved Abilify (aripiprazole) as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. Source: FDA website.
New Indications 02-22-11
Antipsychotic drugs
The Food and Drug Administration (FDA) announced an update to the Pregnancy section of the prescribing information for the entire class of antipsychotic medications. The new label will include more information on the potential risk for abnormal muscle movements and withdrawal symptoms in newborns whose mothers received these types of medications during the third trimester of pregnancy. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm Source: FDA website.
Drug Warning 02-22-11
Allegra over the counter (OTC)
The Food and Drug Administration (FDA) approved Allegra (fexofenadine) product lines to be marketed over-the-counter (OTC) for adults and children 2 years of age and older. Allegra-D (fexofenadine/pseudoephedrine) OTC use was also approved for adults and children 12 years of age and older. These products will be available OTC in March 2011 in their original prescription strengths. Additional information can be found at www.allegra.com
Over the Counter Products 01-26-11
Intuniv
The Food and Drug Administration (FDA) approved Intuniv (guanfacine extended release tablets) as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old. Source: FDA
New Indications 02-28-11
Edarbi
The Food and Drug Administration (FDA) approved Edarbi (azilsartan medoxomil) for the treatment of hypertension in adults. Source: FDA website
New Drug 02-25-11
Daliresp
The Food and Drug Administration (FDA) approved Daliresp (roflumilast tablets) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Source: FDA website.
New Drug 03-01-11
Abacavir
The Food and Drug Administration (FDA) gave an update on an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on this risk in the past. The FDA has conducted a review of 26 clinical trials evaluating abacavir. They concluded that the studies did not show an increased risk of heart attack associated with the use of abacavir. The FDA will continue to communicate any new information on this issue. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245190.htm Source: FDA website.
Drug Warning 03-01-11
Proton Pump Inhibitors
The Food and Drug Administration (FDA) announced that prescription proton pump inhibitors (PPIs) may cause low serum magnesium levels if taken for prolonged periods of time, usually longer than one year. Low serum magnesium levels can result in serious adverse events including muscle spasm, irregular heartbeat, and seizures. Patients taking PPIs should report any adverse events. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm Source: FDA website.
Drug Warning 03-02-11
Banzel Oral Suspension
The Food and Drug Administration (FDA) approved BanzelTM (rufinamide) oral suspension for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients ≥4 years old. Source: FDA website
New Drug 03-04-11
Topamax
The Food and Drug Administration (FDA) announced an increased risk of development of cleft lip and/or cleft palate in infants born to women treated with Topamax (topiramate) during pregnancy. The FDA will be placing Topamax in Pregnancy Category D and product labeling will be updated with this new information. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm Source: FDA website.
Drug Warning 03-04-11
Unapproved cough, cold, allergy products
The Food and Drug Administration (FDA) announced the removal of certain unapproved prescription cough, cold, and allergy products from the United States market. These products have not been evaluated by the agency for safety, effectiveness, and quality. More details and a list of affected products can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245279.htm Souce: FDA website
Market Withdrawal 03-02-11
Kaletra
The Food and Drug Administration (FDA) announced that serious health problems have been reported in premature infants receiving Kaletra (lopinavir/ritonavir) oral solution which is used in combination with other agents for the treatment of HIV-1 infection. This product contains alcohol and propylene glycol. Premature babies may be at an increased risk for health problems due to their decreased ability to eliminate propylene glycol. This could lead to adverse events such as heart, kidney, or breathing problems. The drug label will be revised with this warning and recommendations for use of this drug in these individuals. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm246167.htm Source: FDA website
Drug Warning 03-08-11
Benlysta
The Food and Drug Administration (FDA) approved Benlysta (belimumab for injection) for the treatment of active systemic lupus erythematosus (SLE). Source: FDA website.
New Drug 03-09-11
American Regent injectable products
The Food and Drug Administration (FDA) announced an update regarding a previous recall of certain American Regent injectable products due to the presence of visible particles in some vials. Details and affected products can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm
Drug Recall 03-17-11
Zyclara
The Food and Drug Administration (FDA) approved Zyclara (imiquimod cream) for the treatment of external genital and perianal warts in individuals ≥ 12 years of age.
New Indications 03-25-11
Yervoy
The Food and Drug Administration (FDA) approved Yervoy (ipilimumab injection) for the treatment of late stage (metastatic) melanoma.
New Drug 03-25-11
Citalopram and finasteride
The manufacturer, Greenstone LLC, issued a voluntary recall of medicines with lot number FI0510058-A. Bottles labeled as citalopram may contain finasteride. The recall includes citalopram 10 mg tablets (100 count bottle) and finasteride 5 mg tablets (90 count bottle). Details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248595.htm. Source: FDA website.
Drug Recall 03-28-11
Irinotecan hydrochloride injection
The manufacturer, APP Pharmaceuticals, Inc., issued a voluntary recall of five lots of irinotecan hydrochloride injection due to the presence of a fungal microbial contaminant in one lot. Details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248598.htm. Source: FDA website.
Drug Recall 03-28-11
Pradaxa
The Food and Drug Administration (FDA) is announcing to consumers important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate). Due to the risk of product breakdown from moisture and loss of potency, Pradaxa capsules should only be dispensed and stored in the original bottle or blister package. Details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249005.htm. Source: FDA website.
Drug Warning 03-30-11
Viramune XR
The Food and Drug Administration (FDA) approved Viramune XR (nevirapine extended release tablets) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults. Source: FDA website.
New Drug 04-05-11
Vandetanib
The Food and Drug Administration (FDA) approved Vandetanib for the treatment of metastatic medullary thyroid cancer. A brand name has not yet been approved. Source: FDA website.
New Drug 04-06-11
Horizant
The Food and Drug Administration (FDA) approved Horizant (gabapentin enacarbil extended release tablets) for the treatment of restless legs syndrome. Source: FDA website.
New Drug 04-06-11
Benzocaine topical products
The Food and Drug Administration (FDA) is announcing reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine topical products. Products affected include sprays used during medical procedures and gels and liquids sold over-the-counter (OTC) for relief of pain from conditions such as teething, canker sores, and mouth/gum irritation. Symptoms of this condition include pale, gray, or blue colored skin, lips, and nail beds, headache, lightheadeness, shortness of breath, fatigue, and rapid heart rate. Benzocaine products should not be used on children less than 2 years of age unless under the advice and supervision of a healthcare professional. Recommendations in the label should be followed and products should be stored out of reach of children. Consumers should talk to their healthcare provider about using benzocaine. The FDA will continue to evaluate. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250264.htm. Source: FDA website.
Drug Warning 04-07-11
Sylatron
The Food and Drug Administration (FDA) approved Sylatron (peginterferon alfa-2b injection) for the adjuvant treatment of melanoma. Source: FDA website.
New Drug 04-12-11
Invega
The Food and Drug Administration (FDA) approved Invega (paliperidone extended-release tablets) for the treatment of schizophrenia in adolescents 12-17 years of age. Source: FDA website.
New Indications 04-11-11
Revlimid
The Food and Drug Administration (FDA) is announcing the results from clinical trials that have found that individuals treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer. The agency has not recommended any changes for the use of Revlimid at this time but is reviewing all available data. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm Source: FDA website.
Drug Warning 04-08-11
Tumor necrosis factor (TNF) blockers, Azathioprine, and/or Mercaptopurine
The Food and Drug Administration (FDA) has received reports of a rare cancer of white blood cells, hepatosplenic T-cell lymphoma, primarily in adolescents and young adults being treated for Crohn's disease and ulcerative colitis with tumor necrosis factors (TNF) blockers, azathioprine, and/or mercaptopurine. TNF blockers include Remicade, Enbrel, Humira, Cimzia, and Simponi. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251443.htm Source: FDA website.
Drug Warning 04-14-11
Topamax
The manufacturer issued a recall of 2 lots of Topamax (topiramate) 100 mg tablets due to reports of a musty odor caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is not considered toxic but there have been several reports of temporary gastrointestinal symptoms. Details of this recall can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251556.htm Source: FDA website.
Drug Recall 04-15-11
Lansoprazole delayed-release orally disintegrating tablets
The Food and Drug Administration (FDA) has received reports that Teva Pharmaceuticals' lansoprazole delayed-release orally disintegrating tablets have clogged and blocked oral syringes and feeding tubes (gastric and jejunostomy types) when the medication is given as a suspension through these devices. Teva has voluntarily withdrawn the product from distribution but some product may remain available. Patients and caregivers should not administer the product through oral syringes and/or feeding tubes. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251575.htm Source: FDA website.
Drug Warning 04-15-11
Actemra
The Food and Drug Administration (FDA) approved Actemra (tocilizumab injection) for the treatment of systemic juvenile idiopathic arthritis (SJIA). Source: FDA website.
New Indications 04-18-11
Benicar
After reviewing clinical trial information, the Food and Drug Administration (FDA) has determined that the benefits of Benicar (olmesartan) continue to outweigh its potential risks when used for the treatment of hypertension according to the prescribing information. Previously, data showed a possible risk of death due to a cardiovascular cause in patients with diabetes taking Benicar. The FDA will continue to review any additional data. Patients should consult their health care professional if they have any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215249.htm Source: FDA website.
Drug Warning 04-14-11
Long-acting beta-agonists (LABAs)
The Food and Drug Administration (FDA) is requiring the manufacturers of long-acting beta-agonists (LABAs) used in the treatment of asthma to conduct five controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone in the treatment of asthma. This request will aid in the further evaluation of the safety of LABAs when used in combination with inhaled corticosteroids. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm Source: FDA website.
Drug Warning 04-15-11
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with corticosteroids for the treatment of adults with Wegener’s granulomatosis and microscopic polyangiitis, 2 forms of severe vasculitis. Source: FDA website.
New Indications 04-20-11
Tysabri
The Food and Drug Administration (FDA) has updated the Tysabri® prescribing information with new information regarding the amount of risk of progressive multifocal leukoencephalopathy (PML) associated with Tysabri use. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm Source: FDA website.
Drug Warning 04-22-11
Fusilev
The Food and Drug Administration (FDA) approved FusilevTM(levoleucovorin injection) ready-to-use (RTU) formulation. The RTU formulation does not require reconstitution and is a higher strength than the currently available product. Source: FDA website.
New Drug 04-22-11
Menactra
The Food and Drug Administration (FDA) approved Menactra® (meningococcal vaccine groups A C Y W-135 conjugate) for the immunization of infants and children 9-23 months old. Source: FDA website.
New Indications 04-25-11
Duexis
The Food and Drug Administration (FDA) approved Duexis® (ibuprofen/famotidine) for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Source: FDA website.
New Drug 04-25-11
Lamictal XR
The Food and Drug Administration (FDA) approved Lamictal® XR (lamotrigine extended release tablets) for conversion to monotherapy for partial seizures. Source: FDA website.
New Indications 04-26-11
Zytiga
The Food and Drug Administration (FDA) approved ZytigaTM (abiraterone acetate) for use in combination with prednisone for the treatment of men with metastatic prostate cancer. Source: FDA website.
New Drug 04-28-11
Nexium IV
The Food and Drug Administration (FDA) approved Nexium® IV (esomeprazole sodium) for use in children > 1 month of age for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis when oral therapy is not possible. Source: FDA website.
New Indications 05-02-11
Fusilev
The Food and Drug Administration (FDA) approved FusilevTM (levoleucovorin for injection) for use in combination with 5-fluorouracil for the palliative treatment of individuals with advanced metastatic colorectal cancer. Source: FDA website.
New Indications 05-02-11
Tradjenta
The Food and Drug Administration (FDA) approved TradjentaTM (linagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website.
New Drug 05-03-11
Afinitor
The Food and Drug Administration (FDA) approved Afinitor® (everolimus tablets) for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in individuals with unresectable, locally advanced or metastatic disease. Source: FDA website.
New Indications 05-05-11
Ocudox Convenience Kit
The Food and Drug Administration (FDA) approved OcudoxTM Convenience Kit containing doxycycline hyclate 50 mg capsules, OCuSoft® Lid ScrubTM plus Extra Strength Pre-Moistened Pads, and Tears Again® Advanced Liposome Spray approved for the treatment of acute eyelid disease. Source: FDA website.
New Drug 04-28-11
Coumadin
The manufacturer announced a voluntary recall of one lot of 1,000 count bottles of Coumadin® (warfarin) 5 mg tablets. Testing from a returned bottle found a tablet to be higher in potency than expected. The lot number is 9H49374A with expiration date of September 30, 2012. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm253615.htm Source: FDA website.
Drug Warnings 05-03-11
Fluzone
The Food and Drug Administration (FDA) approved Fluzone® Intradermal (influenza virus vaccine) for immunization of adults 18-64 years old against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website.
New Drug 05-10-11
Victrelis
The Food and Drug Administration (FDA) approved VictrelisTM (boceprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults. Source: FDA website.
New Drug 05-16-11
Edurant
The Food and Drug Administration (FDA) approved EdurantTM (rilpivirine) for use in combination with other antiretroviral agents in the treatment of HIV-1 in treatment naive adults. Source: FDA website.
New Drug 05-20-11
Sutent
The Food and Drug Administration (FDA) approved Sutent® (sunitinib) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in individuals with unresectable locally advanced or metastatic disease. Source: FDA website.
New Indications 05-23-11
Avandia
The Food and Drug Administration (FDA) has announced a modified Risk Evaluation and Mitigation Strategy (REMS) program for Avandia® (rosiglitazone) containing products that includes a restricted access and distribution program. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm Source: FDA website.
Drug Warning 05-18-11
Incivek
The Food and Drug Administration (FDA) approved IncivekTM (telaprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults. Source: FDA website.
New Drug 05-23-11
Dificid
The Food and Drug Administration (FDA) approved DificidTM (fidaxomicin) for the treatment of Clostridium difficile-associated diarrhea. Source: FDA website.
New Drug 05-27-11
Drospirenone
The Food and Drug Administration (FDA) is evaluating results from two studies that show an increased risk of venous thromboembolism in women who use birth control pills that contain drospirenone compared with pills that contain levonorgestrel. Other studies have not shown this increased risk. The FDA will review all available data and will communicate new safety information as it becomes available. If your birth control pill contains drospirenone, do not stop taking it without first talking to your doctor. Tell your doctor if you experience any of the following symptoms: persistent leg pain, severe chest pain, or sudden shortness of breath. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm Source: FDA website.
Drug Warning 05-31-11
Angiotensin Receptor Blockers (ARBs)
The Food and Drug Administration (FDA) completed a review of 31 randomized, controlled clinical trials comparing ARBs to other treatments for hypertension and found no evidence of an increased risk of cancer. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm Source: FDA website.
Drug Warning 06-02-11
Humalog
The Food and Drug Administration (FDA) approved Humalog® (insulin lispro) for continuous insulin infusion pump therapy in children 4 years of age and older with type 1 diabetes. New labeling also includes extension of the time-in-use in the external pump reservoir to a maximum of seven days and extension of the time-in-use of the infusion set and of the infusion set subcutaneous insertion site to a maximum of three days. Source: FDA website.
New Indications 06-08-11
Simvastatin
The Food and Drug Administration (FDA) has recommended limiting the use of the cholesterol lowering medication simvastatin at the highest 80 mg dose due to the increased risk of muscle damage. New contraindications and dose limitations when used with other drugs were also recommended. This affects Zocor® (simvastatin), Vytorin® (ezetimibe/simvastatin), and Simcor® (niacin/simvastatin). Patients should contact their doctor with any questions or concerns. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm Source: FDA website.
Drug Warning 06-09-11
5-alpha reductase inhibitors
The Food and Drug Administration (FDA) announced an update to the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of medications including dutasteride, Proscar®, Propecia®, Avodart®, and JalynTM. The revision will include new information regarding the increased risk of high-grade prostate cancer. Patients should contact their doctor with any questions or concerns about these medications. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm Source: FDA website.
Drug Warning 06-09-11
Victoza
The manufacturer has reminded healthcare professionals of the risk of dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant Victoza® (liraglutide) exposures in rats and mice. Human relevance could not be ruled out. Also, in clinical trials there were more cases of pancreatitis in individuals treated with Victoza compared with those treated with comparators. Patients should contact their doctor with any questions or concerns. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm Source: FDA website.
Drug Warning 06-13-11
Potiga
The Food and Drug Administration (FDA) approved PotigaTM (ezogabine) for the adjunctive treatment of partial onset seizures in adults with epilepsy. Source: FDA website.
New Drug 06-10-11
Risperdal (risperidone) and Requip (ropinirole)
The Food and Drug Administration (FDA) notified healthcare professionals and consumers of reports of medication errors involving individuals who were given Risperdal® (risperidone) and Requip® (ropinirole) and vice versa. Healthcare professionals are reminded to clearly print or spell out the medication name on all prescriptions and to communicate to individuals the name and indication of their prescribed medication. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258905.htm Source: FDA website.
Drug Warning 06-13-11
Rezira
The Food and Drug Administration (FDA) approved ReziraTM (hydrocodone bitartrate/pseudoephedrine) for the relief of cough and nasal congestion associated with common cold in adults 18 years of age and older. Source: FDA website.
New Drug 06-13-11
Zutripro
The Food and Drug Administration (FDA) approved ZutriproTM (hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine) for the relief of cough and nasal congestion associated with common cold and relief of upper respiratory allergy symptoms including nasal congestion in adults 18 years of age and older. Source: FDA website.
New Drug 06-13-11
Creon
The Food and Drug Administration (FDA) approved Creon® (pancrelipase delayed-release capsules) for exocrine pancreatic insufficiency due to cystic fibrosis. Source: FDA website.
New Drug 06-14-11
Actos
The Food and Drug Administration (FDA) provided an update on their ongoing safety review of Actos® (pioglitazone). The FDA concluded that the use of Actos for greater than one year may be associated with an increased risk of bladder cancer. The Warnings and Precautions section of the prescribing information will be updated with this risk for all medications containing pioglitazone. Patient Medication Guides will also be revised. The FDA is recommending that pioglitazone not be used in individuals with active bladder cancer. In addition, caution should be used in those with a prior history of bladder cancer. Patients should contact their doctor with any questions or concerns. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226257.htm Source: FDA website.
Drug Warning 06-15-11
Indomethacin
Bedford Laboratories announced a voluntary recall of Indomethacin for Injection, 1 mg single dose vial (NDC #55390-299-01, Lot 1948138, expiration date September 2011) because it may contain particulate matter. Details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259262.htm Source: FDA website.
Drug Recall 06-15-11
Nulojix
The Food and Drug Administration (FDA) approved NulojixTM (belatacept injection) for prevention of kidney transplant rejection. Source: FDA website.
New Drug 06-15-11
Chantix
The Food and Drug Administration (FDA) notified healthcare professionals and consumers that Chantix® (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in individuals who have cardiovascular disease. The Warnings and Precautions section of the prescribing information and the Medication Guide will be updated. Patients should contact their doctor with any questions or concerns. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm Source: FDA website.
Drug Warning 06-16-11
Istodax
The Food and Drug Administration (FDA) approved Istodax® (romidepsin injection) for the treatment of peripheral T-cell lymphoma in individuals who have received at least one prior therapy. Source: FDA website.
New Indications 06-16-11
Lupron Depot
The Food and Drug Administration (FDA) approved Lupron Depot® 45 mg (leuprolide acetate for depot suspension) six-month administration formulation for symptomatic treatment of advanced prostate cancer. Source: FDA website.
New Drug 06-20-11
Oxecta
The Food and Drug Administration (FDA) approved OxectaTM (oxycodone immediate release) for the management of moderate to severe pain. The formulation is designed to discourage abuse associated with narcotic pain relievers. Source: FDA website.
New Drug 06-17-11
Risperdal and risperidone
Ortho-McNeil-Janssen Pharmaceuticals announced a recall of specific lots of Risperdal® 3 mg tablets and risperidone 2 mg tablets due to an uncharacteristic odor. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259901.htm Source: FDA website.
Drug Recall 06-20-11
Rectiv
The Food and Drug Administration (FDA) approved RectivTM (nitroglycerin ointment) for the treatment of moderate to severe pain associated with chronic anal fissures (cuts or tears). Source: FDA website.
New Drug 06-22-11
Erythropoiesis-Stimulating Agents
The Food and Drug Administration (FDA) notified healthcare professionals of new dosing recommendations for erythropoiesis-stimulating agents (ESAs) used in individuals with chronic kidney disease to treat certain types of anemia (decrease in red blood cells). The new dosing will target a more conservative hemoglobin (protein in red blood cells that carries oxygen) level in order to decrease the risk of cardiovascular adverse events. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260641.htm Source: FDA website.
Drug Warning 06-24-11
Zenpep
The Food and Drug Administration (FDA) approved an infant specific dosage of Zenpep® (pancrelipase delayed-release capsules) for exocrine pancreatic insufficiency due to cystic fibrosis. Source: FDA website.
New Drug 06-17-11
Butalbital/ acetaminophen/ caffeine and Hydrocodone bitartrate/ acetaminophen
Qualitest and the Food and Drug Administration (FDA) announced a recall of specific lots of butalbital/acetaminophen/caffeine 50 mg/325 mg/40 mg tablets and hydrocodone bitartrate/acetaminophen 7.5 mg/500 mg tablets due to the possibility that some bottles may contain incorrect tablets and consumers may unintentionally take butalbital and caffeine instead of hydrocodone. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260915.htm Source: FDA website.
Drug Recall 06-27-11
Endocet
Endo Pharmaceuticals and the Food and Drug Administration (FDA) announced a recall of Endocet® (oxycodone/acetaminophen) 10 mg/325 mg tablets because some bottles may contain different strength tablets. More details can be found at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260979.htm Source: FDA website.
Drug Recall 06-27-11
Valproate products
The Food and Drug Administration (FDA) notified healthcare professionals that children born to mothers who take valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of impaired cognitive development than children exposed to other anti-seizure medications during pregnancy. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm261610.htm Source: FDA website.
Drug Warning 06-30-11
Lazanda
The Food and Drug Administration (FDA) approved Lazanda® (fentanyl nasal spray) for breakthrough cancer pain. Source: FDA website.
New Drug 07-01-11
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) for the prevention of venous blood clots in individuals undergoing knee or hip replacement surgery. Source: FDA website.
New Drug 07-01-11
Arcapta
The Food and Drug Administration (FDA) approved ArcaptaTM (indacaterol inhalation powder) for the maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). Source: FDA website.
New Drug 07-05-11
Nulojix
The manufacturer notified healthcare professionals of the Risk Evaluation and Mitigation Strategy (REMS) that is required for NulojixTM (belatacept) due to the increased risks of post-transplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML) in individuals administered Nulojix. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262210.htm Source: FDA website.
Drug Warning 07-07-11
Boostrix
The Food and Drug Administration (FDA) approved Boostrix® vaccine for use in adults 65 or higher years of age for active booster immunization against tetanus, diphtheria, and pertussis. Source: FDA website.
New Indications 07-11-11
Tamiflu
The Food and Drug Administration (FDA) announced labeling changes for Tamiflu® (oseltamivir phosphate oral suspension) to reduce the possibility of prescribing and dosing confusion which can lead to medication errors. The concentration will be changed from 12 mg/mL to 6 mg/mL. Other changes include the oral dosing device, dosing table, container labels, carton packaging, and compounding instructions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262432.htm Source: FDA website.
Drug Warning 07-11-11
Zenpep
The Food and Drug Administration (FDA) approved Zenpep® (pancrelipase delayed-release) 25,000 lipase units per capsule for treatment of exocrine pancreatic insufficiency. Source: FDA website.
New Drug 07-14-11
Lialda
The Food and Drug Administration (FDA) approved Lialda® (mesalamine delayed-release) tablets for the maintenance of remission in individuals with ulcerative colitis. Source: FDA website.
New Indications 07-05-11
Brilinta
The Food and Drug Administration (FDA) approved BrilintaTM (ticagrelor) tablets for the prevention of thrombotic events in acute coronary syndrome. Source: FDA website.
New Drug 07-21-11
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinum toxinA) injection for the temporary improvement in the appearance of moderate to severe frown lines between the eyebrows in adults. Source: FDA website.
New Indications 07-21-11
Bisphosphonates
The Food and Drug Administration (FDA) announced an ongoing safety review of published studies to determine whether use of oral bisphosphonates is associated with an increased risk of esophageal cancer. The agency has not yet reached a conclusion and will continue to evaluate all data. Patients should talk with their healthcare provider if they have questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264087.htm Source: FDA website.
Drug Warning 07-21-11
Multaq
The Food and Drug Administration (FDA) announced that it is reviewing data from a clinical trial that evaluated the effects of Multaq® (dronedarone) in individuals with permanent atrial fibrillation. The study was stopped early due to an increase in death, stroke and hospitalization for heart failure in those taking Multaq compared with placebo. The FDA is looking at whether the preliminary results of this study apply to individuals taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter. Patients should not stop taking Multaq unless discussed with their health care provider. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm Source: FDA website.
Drug Warning 07-21-11
Chantix
The Food and Drug Administration (FDA) approved updated labeling for Chantix® (varenicline) to include information about efficacy and safety in individuals with cardiovascular disease and chronic obstructive pulmonary disease (COPD). More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm Source: FDA website.
Drug Warning 07-22-11
Gammagard Liquid
The Food and Drug Administration (FDA) approved Gammagard LiquidTM (immune globulin infusion) for subcutaneous administration for primary humoral immunodeficiency in adults and pediatric individuals 2 years of age or more. This will allow for self-administration at home. Source: FDA website.
New Drug 07-25-11
Methylene blue
The Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when methylene blue is administered to individuals taking certain psychiatric medications. Patients should discuss any questions with their healthcare provider. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265476.htm Source: FDA website.
Drug Warning 07-26-11
Zyvox
The Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when Zyvox® (linezolid) is administered to individuals taking certain psychiatric medications. Patients should discuss any questions with their healthcare provider. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265479.htm Source: FDA website.
Drug Warning 07-26-11
Orencia
The Food and Drug Administration (FDA) approved Orencia® (abatacept) self-injectable subcutaneous formulation to treat adults with moderate to severe rheumatoid arthritis. Source: FDA website.
New Drug 08-01-11
Diflucan
The Food and Drug Administration (FDA) is informing patients that treatment with chronic, high doses (400-800 mg/day) of Diflucan® (fluconazole) during the first trimester of pregnancy may be associated with birth defects The risk does not appear to be associated with a single, low dose (150 mg) used to treat vaginal yeast infection. Patients should discuss any concerns with their healthcare providers. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266468.htm Source: FDA website.
Drug Warning 08-03-11
Vasopressin
American Regent, Inc. is announcing a voluntary recall of multiple lots of vasopressin injection because some vials may not maintain potency throughout their shelf-life. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266648.htm Source: FDA website
Drug Recall 08-04-11
Actos
The Food and Drug Administration (FDA) approved updated drug labels for Actos® (pioglitazone) containing medications to include safety information regarding an increased risk of bladder cancer with the use of pioglitazone for more than one year. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226257.htm Source: FDA website.
Drug Warning 08-04-11
Recombinant human growth hormone
The Food and Drug Administration (FDA) has determined that the evidence regarding recombinant human growth hormone (somatropin) and increased risk of death is inconclusive at this time. The agency will continue to review this issue. More details can be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237969.htm Source: FDA website.
Drug Warning 08-04-11
Complera
The Food and Drug Administration (FDA) approved CompleraTM (emtricitabine/rilpivirine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus 1 (HIV-1) in treatment-naïve adults. Source: FDA website.
New Drug 08-11-11
Zelboraf
The Food and Drug Administration (FDA) approved ZelborafTM (vemurafenib tablets) for the treatment of metastatic skin cancer in patients whose tumors express a specific gene mutation. A companion diagnostic test was also approved. Source: FDA website.
New Drug 08-17-11
Lupron Depot-PED
The Food and Drug Administration (FDA) approved Lupron Depot-PED® (leuprolide acetate for depot suspension) 11.25 mg and 30 mg for three-month administration for the treatment of children with central precocious puberty (CPP). Source: FDA website.
New Drug 08-17-11
Adcetris
The Food and Drug Administration (FDA) approved AdcetrisTM (brentuximab vedotin injection) for the treatment of Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). Source: FDA website.
New Drug 08-19-11
Celexa
The Food and Drug Administration (FDA) announced that the antidepressant Celexa® (citalopram) should not be used at doses greater than 40 mg per day because it can cause abnormal heart rhythms. Individuals at greatest risk include those with underlying heart conditions and those predisposed to low blood levels of potassium and magnesium. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm Source: FDA website.
Drug Warning 08-24-11
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA) for the treatment of urinary incontinence in individuals with neurologic conditions and those with multiple sclerosis who have an overactive bladder. Source: FDA website.
New Indications 08-24-11
Firazyr
The Food and Drug Administration (FDA) approved Firazyr® (icatibant injection) for the treatment of acute attacks of hereditary angioedema (HAE). Source: FDA website.
New Drug 08-25-11
Nucynta ER
The Food and Drug Administration (FDA) approved Nucynta® ER (tapentadol extended-release tablets) for the management of moderate to severe chronic pain in adults. Source: FDA website.
New Drug 08-26-11
Saphris
The Food and Drug Administration (FDA) announced that serious allergic reactions have been reported with the use of Saphris® (asenapine), sometimes after the first dose. Product labeling will be updated. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270600.htm Source: FDA website.
Drug Warning 09-01-11
Reclast
The Food and Drug Administration (FDA) announced updates to the product label for Reclast® (zoledronic acid) regarding the risk of kidney failure. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270464.htm Source: FDA website.
Drug Warning 09-01-11
Tumor necrosis factor-alpha (TNF-alpha) blockers
The Food and Drug Administration (FDA) announced updates to the product labels for tumor necrosis factor-alpha (TNF-alpha) blockers to include the risk of infection from certain bacterial pathogens. This class of medications is used to treat various conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htm Source: FDA website.
Drug Warning 09-07-11
Zofran
The Food and Drug Administration (FDA) announced an ongoing safety review and labeling changes for Zofran® (ondansetron) and generics due to a possible risk of developing abnormal heart rhythms. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272041.htm Source: FDA website.
Drug Warning 09-15-11
Qualitest Pharmaceuticals Oral Contraceptives
Qualitest Pharmaceuticals announced a voluntary recall of several of its oral contraceptives due to a packaging error that could lead to an incorrect daily regimen. Certain lots of Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem are affected. Contact your healthcare professional with any questions. More details including a link to a listing of recalled lots can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272237.htm Source: FDA website.
Drug Recall 09-16-11
Prolia
The Food and Drug Administration (FDA) approved Prolia® (denosumab injection) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture. Source: FDA website
New Indications 09-21-12
Soliris
The Food and Drug Administration (FDA) approved Soliris®(eculizumab injection) for the treatment of atypical hemolytic uremic syndrome. Source: FDA website.
New Indications 09-23-11
Remicade
The Food and Drug Administration (FDA) approved Remicade® (infliximab injection) for the treatment of moderately to severely active ulcerative colitis in pediatric individuals who have had an inadequate response to conventional therapy. Source: FDA website.
New Indications 09-26-11
Drospirenone Containing Oral Contraceptives
The Food and Drug Administration (FDA) communicated regarding an ongoing safety review of birth control pills containing drospirenone and a potential increased risk of blood clots. The FDA will continue to evaluate this issue. Contact your healthcare professional with any questions. More details including names of drospirenone-containing products can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm Source: FDA website.
Drug Warning 09-26-11
Juvisync
The Food and Drug Administration (FDA) approved JuvisyncTM (sitagliptin/simvastatin) to treat adults with type 2 diabetes and high cholesterol.
New Drug 10-07-11
Cialis
The Food and Drug Administration (FDA) approved Cialis® (tadalafil) for the treatment of men who have signs and symptoms of benign prostatic hyperplasia (BPH) or erectile dysfunction (ED) and signs and symptoms of BPH.
New Indications 10-07-11
Combivent Respimat
The Food and Drug Administration (FDA) approved Combivent® Respimat® (ipratropium bromide/albuterol) propellant-free inhaler that uses a slow-moving mist to deliver ipratropium bromide and albuterol in individuals with chronic obstructive pulmonary disease (COPD).
New Drug 10-07-11
Fluoxetine
The Food and Drug Administration (FDA) approved Fluoxetine 60 mg tablet dosage strength for the treatment of major depressive disorder, or obsessive-compulsive disorder in adults and pediatrics, and bulimia nervosa, or panic disorder in adults.
New Drug 10-11-11
Sprycel
The Food and Drug Administration (FDA) announced that Sprycel® (dasatinib) may increase the risk of pulmonary arterial hypertension (PAH). Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm275176.htm
Drug Warning 10-11-11
Androderm
The Food and Drug Administration (FDA) approved Androderm® (testosterone patch) in 2 mg/day and 4 mg/day formulations.
New Drug 10-21-11
Byetta
The Food and Drug Administration (FDA) approved Byetta® (exenatide injection) for use as add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.
New Indications 10-20-11
Ferriprox
The Food and Drug Administration (FDA) approved Ferriprox® (deferiprone) for the treatment of iron overload due to blood transfusions.
New Drug 10-17-11
Zyvox
The Food and Drug Administration (FDA) updated a previous communication on the potential drug interaction between Zyvox® (linezolid) or methylene blue and serotonergic psychiatric medications to indicate that not all serotonergic psychiatric drugs have the same ability to cause serotonin syndrome when taken with Zyvox or methylene blue. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265479.htm
Drug Warning 10-21-11
Onfi
The Food and Drug Administration (FDA) approved OnfiTM (clobazam) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS).
New Drug 10-24-11
Acanya
The Food and Drug Administration (FDA) approved AcanyaTM (clindamycin phosphate/benzoyl peroxide gel) in premixed ready-to-use pump container. This new product will replace the currently available jar container which requires premixing in the pharmacy.
New Drug 10-24-11
Xigris
The Food and Drug Administration (FDA) communicated that Eli Lilly announced a worldwide voluntary market withdrawal of Xigris® which is indicated for severe sepsis in individuals who have a high risk of death. The withdrawal is due to lack of survival benefit in a recently completed clinical trial. Individuals currently treated with Xigris should have treatment discontinued by their healthcare professional. Therapy should not be initiated for new cases. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm277143.htm
Voluntary Withdrawal 10-25-11
Chantix
The Food and Drug Administration (FDA) has reviewed the results of two FDA-sponsored trials evaluating the risk of neuropsychiatric adverse events associated with Chantix®(varenicline) used for smoking cessation. The studies did not find a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy; however, the trials had numerous limitations. Healthcare professionals should continue to monitor neuropsychiatric symptoms with Chantix. Results from a manufacturer safety trial are expected in 2017. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079818.htm
Drug Warning 10-24-11
Erbitux
The Food and Drug Administration (FDA) approved Erbitux® (cetuximab) for the treatment of metastatic head and neck cancer in combination with other chemotherapy. Source: FDA website.
New Indications 11-07-11
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban) to reduce the risk of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation. Source: FDA website.
New Indications 11-04-11
Exparel
The Food and Drug Administration (FDA) approved ExparelTM (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia. Source: FDA website.
New Drug 10-31-11
Nexplanon
The Food and Drug Administration (FDA) approved Nexplanon® (etonogestrel implant) for the prevention of pregnancy in women for up to three years. Source: FDA website.
New Drug 11-09-11
Bupropion controlled release
The Food and Drug Administration (FDA) approved a single-dose 450 mg formulation of bupropion controlled release for the treatment of major depressive disorder. Source: http://www.intelgenx.com/
New Drug 11-11-11
Erwinaze
The Food and Drug Administration (FDA) approved Erwinaze® (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in individuals with hypersensitivity to E. coli-derived asparaginase. Source: FDA website.
New Drug 11-18-11
Intermezzo
The Food and Drug Administration (FDA) approved Intermezzo® (zolpidem sublingual tablets) for the treatment of insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. Source: FDA website.
New Drug 11-23-11
Anturol
The Food and Drug Administration (FDA) approved Anturol® (oxybutynin topical gel) for the treatment of overactive bladder. Source: FDA website.
New Drug 12-08-11
Opana ER
The Food and Drug Administration (FDA) approved Opana® ER (oxymorphone extended-release tablets) for the relief of moderate-to-severe pain in individuals requiring continuous, around-the-clock opioid treatment for an extended period of time. The tablets are designed to be crush-resistant. Source: www.endo.com
New Drug 12-12-11
Jakafi
The Food and Drug Administration (FDA) approved JakafiTM (ruxolitinib) for the treatment of individuals with intermediate or high-risk myelofibrosis (MF). Source: FDA website.
New Drug 11-16-11
Eylea
The Food and Drug Administration (FDA) approved EyleaTM (aflibercept injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD). Source: FDA website.
New Drug 11-21-11
Drospirenone containing oral contraceptives
The Food and Drug Administration (FDA) announced the release of the final report of the FDA-funded study to evaluate the risk of blood clots associated with several different hormonal contraceptives including drospirenone. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm Source: FDA website.
Drug Warning 10-27-11
Stimulant medications
The Food and Drug Administration (FDA) notified the public that a recently completed trial in children and young adults treated with medications for attention deficit/hyperactivity disorder (ADHD) has not shown an association between certain ADHD medications and cardiovascular adverse events. The FDA will continue to recommend that healthcare professionals prescribe these medications according to product labels. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm Source: FDA website.
Drug Warning 11-01-11
Tumor necrosis factor (TNF) blockers, Azathioprine and/or Mercaptopurine
The Food and Drug Administration (FDA) provided an update on reports of Hepatosplenic T-cell Lymphoma in adolescents and young adults who are being treated with tumor necrosis factor (TNF) blockers, azathioprine, and/or mercaptopurine. The agency reminded healthcare professionals they should report any cases. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251443.htm Source: FDA website.
Drug Warning 11-04-11
Rosiglitazone containing medications
The Food and Drug Administration (FDA) reminded healthcare professionals and consumers of the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medications. After November 18, 2011, these medications will only be available by mail order through specially certified pharmacies. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm277629.htm Source: FDA website.
Drug Warning 11-04-11
Trilipix
The Food and Drug Administration (FDA) notified healthcare professionals of a labeling update for TrilipixTM (fenofibric acid). The agency reviewed data from a clinical trial and found no significant difference in the risk of experiencing a major adverse cardiac event between individuals treated with fenofibrate plus simvastatin compared with simvastatin alone. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm279185.htm Source: FDA website.
Drug Warning 11-09-11
Pradaxa
The Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding in individuals taking Pradaxa® (dabigatran). The agency recommends that healthcare professionals continue to follow the recommendations in the drug label. They will communicate any new information when it becomes available. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm Source: FDA website.
Drug Warning 12-07-11
Nplate and Promacta
The Food and Drug Administration (FDA) approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for Nplate® (romiplostim) and Promacta® (eltrombopag) including the removal of requirements for restricted distribution and additional safety data collection. Contact your healthcare professional with any questions. More details can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm280165.htm Source: FDA website.
Drug Warning 12-06-11
Edarbyclor
The Food and Drug Administration (FDA) approved EdarbyclorTM (azilsartan medoxomil/chlorthalidone) for the treatment of hypertension in adults. Source: FDA website.
New Drug 12-20-11
Subsys
The Food and Drug Administration (FDA) approved Subsys® (fentanyl sublingual spray) for the management of breakthrough cancer pain in individuals 18 years of age and older. Source: FDA website.
New Drug 01-04-12
Voraxaze
The Food and Drug Administration (FDA) approved Voraxaze® (glucarpidase) for the treatment of toxic levels of methotrexate in the blood due to kidney failure. Source: FDA website.
New Drug 01-17-12
Viread
The Food and Drug Administration (FDA) approved Viread® (tenofovir disoproxil fumarate) for in combination with other antiretrovirals for the treatment of human immunodeficiency virus-1 (HIV-1) infection in pediatric individuals 2-12 years old. Also approved are three lower-strength tablets in doses of 150 mg, 200 mg, and 250 mg for children ages 6-12 and an oral powder formulation for children ages 2-5. Source: FDA website.
New Indications 01-19-12
Prevnar
The Food and Drug Administration (FDA) approved Prevnar 13TM (pneumococcal 13-valent conjugate vaccine) for use in adults aged 50 and older to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae. Source: FDA website.
New Indications 12-30-11
Adcetris
The Food and Drug Administration (FDA) reported that two additional cases of progressive multifocal leukoencephalopathy (PML), a serious brain infection, have been reported with AdcetrisTM (brentuximab vedotin). Updates to the drug label will be made. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287710.htm Source: FDA website.
Drug Warning 01-13-12
Selective serotonin reuptake inhibitors
The Food and Drug Administration (FDA) reported on the use of selective serotonin reuptake inhibitors (SSRIs) by women during pregnancy and the potential risk of persistent pulmonary hypertension of the newborn (PPHN). There has been conflicting data on this potential risk and the agency is unable to reach a conclusion at this time. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm283696.htm Source: FDA website.
Drug Warning 12-14-11
Zocor
The Food and Drug Administration (FDA) announced that it has revised the dose limitation for Zocor® (simvastatin) from 10 mg to 20 mg when it is co-administered with amiodarone. All simvastatin drug labels have been updated. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm Source: FDA website.
Drug Warning 12-15-11
Multaq
The Food and Drug Administration (FDA) completed a safety review of Multaq® (dronedarone) which showed an increased risk of serious cardiovascular events, including death, when used by individuals with permanent atrial fibrillation. The drug label will be revised and recommendations provided. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm Source: FDA website.
Drug Warning 12-20-11
Gilenya
The Food and Drug Administration (FDA) received a report of an individual with multiple sclerosis who died within 24 hours of taking the first dose of Gilenya® (fingolimod). Currently, the FDA cannot conclude whether the drug resulted in death. The agency will continue to evaluate and will communicate any new information. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm Source: FDA website.
Drug Warning 12-20-11
Bedford Laboratories Polymyxin B and Vecuronium bromide
Bedford Laboratories released guidance on the nationwide voluntary recall originally issued on August 2, 2011 for certain lots of Polymyxin B for injection and Vecuronium Bromide for injection due to visible glass particles found in a limited number of vials. Contact your healthcare provider with any questions. More details may be found including affected lots at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287411.htm Source: FDA website.
Drug Recall 01-12-12
Endo Pharmaceuticals Opiate Products
The Food and Drug Administration (FDA) reported a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health. Tablets from one product type may have carried over into packaging of another product. The FDA is advising that individuals should examine opiate medications made by Endo to ensure all tablets are the same. Contact your healthcare provider with any questions. More details may be found including affected products at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm286280.htm Source: FDA website.
Drug Warning 01-09-12
Zetonna
The Food and Drug Administration (FDA) approved ZetonnaTM (ciclesonide) nasal aerosol to treat the symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. Source: FDA website.
New Drug 01-20-12
Picato
The Food and Drug Administration (FDA) approved Picato® (ingenol mebutate gel) for the topical treatment of actinic keratosis. Source: FDA website.
New Drug 01-23-12
Inlyta
The Food and Drug Administration (FDA) approved Inlyta® (axitinib tablets) for the treatment of advanced kidney cancer in individuals who have not responded to another drug for this type of cancer. Source: FDA website.
New Drug 01-27-12
Bydureon
The Food and Drug Administration (FDA) approved BydureonTM (exenatide long-acting release) for once weekly injection for type 2 diabetes. Source: FDA website.
New Drug 01-27-12
Erivedge
The Food and Drug Administration (FDA) approved ErivedgeTM (vismodegib capsules) for the treatment of advanced basal cell carcinoma. Source: FDA website.
New Drug 01-30-12
Jentadueto
The Food and Drug Administration (FDA) approved JentaduetoTM (linagliptin/metformin) for the treatment of type 2 diabetes. Source: FDA website.
New Drug 01-31-12
Janumet XR
The Food and Drug Administration (FDA) approved Janumet® XR (sitagliptin/metformin) for the treatment of type 2 diabetes. Source: FDA website.
New Drug 02-03-12
Kalydeco
The Food and Drug Administration (FDA) approved KalydecoTM (ivacaftor tablets) for the treatment of cystic fibrosis (CF) in individuals 6 years of age and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator gene. Source: FDA website.
New Drug 02-03-12
SKLICE
The Food and Drug Administration (FDA) approved SKLICETM (ivermectin lotion) for the topical treatment of head lice in individuals 6 months of age and older. Source: FDA website.
New Drug 02-07-12
Zioptan
The Food and Drug Administration (FDA) approved ZioptanTM (tafluprost ophthalmic solution) for reducing elevated intraocular pressure in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website.
New Drug 02-13-12
Keppra
The Food and Drug Administration (FDA) approved Keppra® (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures in children one month of age and older with epilepsy. Source: FDA website.
New Indications 01-26-12
Vyvanse
The Food and Drug Administration (FDA) approved Vyvanse® (lisdexamfetamine dimesylate) for the maintenance treatment of adults with attention deficit hyperactivity disorder (ADHD). Source: FDA website.
New Indications 01-31-12
Gris-PEG
Pedinol Pharmacal Inc. notified healthcare professionals and consumers of a potential issue with Gris-PEG® (griseofulvin ultramicrosize) 125 mg and 250 mg manufactured and packaged by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Tablets from one product type may have carried over into packaging of another product. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290295.htm Source: FDA website.
Drug Warning 02-03-12
Acetylcysteine
Bedford Laboratories issued an update to the voluntary recall communicated on December 20, 2011 of one lot of Acetylcysteine Solution (Roxane Laboratories) due to a visible glass particle in a vial. The lot was identified as lot 1877093 with expiration date of 06/2013. Contact your healthcare profession with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290219.htm Source: FDA website.
Drug Warning 02-03-12
Proton pump inhibitors
The Food and Drug Administration (FDA) notified consumers that the use of PPIs may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD). Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290838.htm Source: FDA website.
Drug Warning 02-03-12
Tysabri
The Food and Drug Administration (FDA) notified healthcare professionals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). Anti-JCV antibody status may be determined using a validated anti-JCV antibody detection test. The Stratify JCV Antibody ELISA test2 was approved by the FDA. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm Source: FDA website.
Drug Warning 01-20-12
Lo/Ovral-28
Pfizer notified healthcare professionals and consumers of a recall of 14 lots of Lo/Ovral®-28 (norgestrel/ethinyl estradiol tablets) and 14 lots of Lo/Ovral-28 generic. The recall is due to some blister packs possibly containing an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. This poses a risk for unintended pregnancy. Contact your healthcare professional with any questions. More details including affected lot numbers may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289803.htm Source: FDA website.
Drug Warning 02-01-12
Victrelis
The Food and Drug Administration (FDA) notified healthcare professionals and consumers that drug interactions between VictrelisTM (boceprevir) for hepatitis C and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medications when they are taken together. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm Source: FDA website.
Drug Warning 02-09-12
Avastin
The Food and Drug Administration (FDA) notified healthcare professionals and consumers about a counterfeit version of Avastin® (bevacizumab) 400 mg/16 mL which may have been purchased and used by some medical practices in the United States. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm Source: FDA website.
Drug Warning 02-14-12
Bio-T-Gel
The Food and Drug Administration (FDA) approved Bio-T-GelTM (testosterone transdermal gel) for the treatment of hypogonadism in men. Source: FDA website.
New Drug 02-14-12
Korlym
The Food and Drug Administration (FDA) approved KorlymTM (mifepristone) for the treatment of individuals with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Source: FDA website.
New Drug 02-21-12
Norgestimate and ethinyl estradiol tablets
Glenmark Generics issued a recall of seven lots of norgestimate and ethinyl estradiol tablets due to a packaging error where select blisters were rotated within the card, reversing the weekly tablet orientation. The daily regimen for these oral contraceptives may be incorrect and pose a risk for unintended pregnancy. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293385.htm Source: FDA website.
Drug Recall 02-27-12
Avonex
The Food and Drug Administration (FDA) approved Avonex® PenTM (interferon beta-1a 30 mcg/0.5 mL solution for injection) for relapsing forms of multiple sclerosis. Source: FDA website.
New Drug 02-28-12
Statins
The Food and Drug Administration (FDA) approved safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from the labels. Information about the potential for non-serious and reversible cognitive adverse effects and reports of increased blood sugar and glycosylated hemoglocin (HbA1c) levels has been added to statin labels. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293670.htm Source: FDA website.
Drug Warning 02-28-12
FluMist Quadrivalent
The Food and Drug Administration (FDA) approved FluMist® Quadrivalent (influenza virus vaccine live intranasal) for seasonal flu prevention in individuals aged 2 to 49 years. Source: FDA website.
New Drug 03-02-12
Statins and HIV or Hepatitis C drugs
The Food and Drug Administration (FDA) announced updates to prescribing information regarding interactions between protease inhibitors and certain statin drugs used to lower cholesterol. Certain protease inhibitors are used to treat human immunodeficiency virus (HIV) and others are used to treat hepatitic C infection. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm294294.htm Source: FDA website.
Drug Warning 03-01-12
Ultresa
The Food and Drug Administration (FDA) approved UltresaTM (pancrelipase delayed release capsules) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Source: FDA website.
New Drug 03-02-12
Viokace
The Food and Drug Administration (FDA) approved ViokaceTM (pancrelipase delayed release tablets) for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Source: FDA website.
New Drug 03-02-12
Surfaxin
The Food and Drug Administration (FDA) approved Surfaxin® (lucinactant intratracheal suspension) for the prevention of respiratory distress syndrome (RDS) in high-risk premature infants. Source: FDA website.
New Drug 03-06-12
Giazo
The Food and Drug Administration (FDA) approved GiazoTM (balsalazide disodium) 1,100 mg tablet for the treatment of ulcerative colitis in male patients. Source: FDA website.
New Drug 02-03-12
ProAir HFA
The Food and Drug Administration (FDA) approved ProAir® HFA (albuterol sulfate inhalation aerosol) with a dose counter for use in individuals > 4 years of age for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Source: FDA website.
New Drug 03-08-12
Binosto
The Food and Drug Administration (FDA) approved Binosto® (alendronate sodium effervescent tablets) for the once-weekly treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. Source: www.effrx.com.
New Drug 03-14-12
Natazia
The Food and Drug Administration (FDA) approved NataziaTM (estradiol valerate/dienogest) for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus in women who choose an oral contraceptive for contraception. Source: FDA website.
New Indications 03-15-12
Intelence
The Food and Drug Administration (FDA) approved Intelence® (etravirine tablets) for the treatment of human immunodeficiency virus 1 (HIV-1) in treatment-experienced pediatric patients ages 6 to less than 18 years old who are experiencing virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretrovirals. Source: FDA website.
New Indications 03-27-12
Omontys
The Food and Drug Administration (FDA) approved Omontys® (peginesatide injection) for the once monthly treatment of anemia due to chronic kidney disease in adults on dialysis. Source: FDA website.
New Drug 03-27-12
QNASL
The Food and Drug Administration (FDA) approved QNASLTM (beclomethasone dipropionate nasal aerosol) for the treatment of seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. QNASL is a non-aqueous spray delivered by hydrofluoroalkane (HFA). Source: FDA website.
New Drug 03-26-12
Argatroban
Eagle Pharmaceuticals announced a voluntary recall of all four lots of argatroban injection, 50 mg per 50 mL from the market due to the potential for visible particulates. Contact your health care provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm297100.htm Source: FDA website.
Drug Recall 03-23-12
Celexa
The Food and Drug Administration (FDA) has clarified dosing and warning recommendations for the antidepressant Celexa® (citalopram) and its generics regarding the potential risk of abnormal heart rhythms when used at doses greater than 40 mg per day. Contact your health care provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm297624.htm Source: FDA website.
Drug Warning 03-28-12
Neupro
The Food and Drug Administration (FDA) approved Neupro® (rotigotine transdermal system) for the treatment of signs and symptoms of advanced stage Parkinson's disease (PD) and as a treatment for moderate-to-severe restless legs syndrome (RLS). This is a new formulation of Neupro following a recall of the original formulation in April 2008 due to the formation of crystals in the patches. The original formulation was approved for early stage Parkinson's disease. Source: FDA website.
New Drug 04-03-12
Drospirenone-containing birth control pills
The Food and Drug Administration (FDA) has completed its review of recent studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. The agency has concluded that these pills may be associated with a higher risk for blood clots than other progestin-containing pills. The product labeling will be updated. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm Source: FDA website.
Drug Warning 04-10-12
Fentanyl transdermal patches
The Food and Drug Administration (FDA) reminded the public of the importance of appropriate storage, use, application, and disposal of all fentanyl patches in order to prevent potential life-threatening harm from accidental exposure to fentanyl. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Drugs/DrugSafety/ucm300747.htm Source: FDA website.
Drug Warning 04-18-12
Aliskiren-containing medications
The Food and Drug Administration (FDA) has announced possible risks associated with the use of blood pressure medications containing aliskiren along with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in individuals with diabetes or renal impairment. Labels for products containing aliskiren are being updated. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm Source: FDA website.
Drug Warning 04-20-12
Victrelis
The Food and Drug Administration (FDA) has announced that the labeling for VictrelisTM (boceprevir), a protease inhibitor used for hepatitis C, has been updated to state that co-administration with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors is not recommended. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm Source: FDA website.
Drug Warning 04-26-12
Votrient
The Food and Drug Administration (FDA) approved Votrient® (pazopanib tablets) for the treatment of advanced soft tissue sarcoma in individuals who have received prior chemotherapy. Source: FDA website.
New Indications 04-27-12
Afinitor
The Food and Drug Administration (FDA) approved Afinitor® (everolimus tablets) for the treatment of adults with non-cancerous kidney tumors. Source: FDA website.
New Indications 04-27-12
Stendra
The Food and Drug Administration (FDA) approved StendraTM (avanafil tablets) for the treatment of erectile dysfunction (ED). Source: FDA website.
New Drug 05-02-12
Elelyso
The Food and Drug Administration (FDA) approved ElelysoTM (taliglucerase alfa injection) for the treatment of Type 1 Gaucher disease. Source: FDA website.
New Drug 05-02-12
Dymista
The Food and Drug Administration (FDA) approved DymistaTM (azelastine/fluticasone propionate nasal spray) for the treatment of seasonal allergic rhinitis. Source: FDA website.
New Drug 05-02-12
Revlimid
The Food and Drug Administration (FDA) notified the public of an ongoing safety review of Revlimid® (lenalidomide) due to an increased risk of developing new malignancies in individuals with newly diagnosed multiple myeloma receiving Revlimid. Drug labeling has been updated. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm Source: FDA website.
Drug Warning 05-07-12
Fabior
The Food and Drug Administration (FDA) approved FabiorTM (tazarotene 0.1% foam) for the treatment of acne vulgaris in individuals 12 years of age and older. Source: FDA website.
New Drug 05-11-12
Omeclamox-Pak
The Food and Drug Administration (FDA) approved Omeclamox-Pak® (omeprazole delayed-release 20 mg capsules, clarithromycin 500 mg tablets, and amoxicillin 500 mg capsules) as a ten-day therapy for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease to eradicate H. pylori in adults. Source: FDA website.
New Drug 05-15-12
Gilenya
The Food and Drug Administration (FDA) has completed an evaluation of data and reports of individuals who died of cardiovascular events or unknown causes after receiving a dose of Gilenya® (fingolimod). The agency could not definitively conclude that Gilenya was related to any of the deaths, however, they remain concerned. Healthcare professionals are advised to review the updated drug label containing monitoring recommendations and new contraindications. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm Source: FDA website.
Drug Warning 05-14-12
Zithromax
The Food and Drug Administration (FDA) announced they are aware of a recently published study reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in individuals treated with a 5-day course of Zithromax® (azithromycin). The agency is reviewing this study and will communicate any additional information once it becomes available. Do not stop taking Zithromax without talking to your healthcare professional. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Source: FDA website.
Drug Warning 05-17-12
Pertzye
The Food and Drug Administration (FDA) approved Pertzye® (pancrelipase delayed-release capsules) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Source: FDA website.
New Drug 05-18-12
Levemir
The Food and Drug Administration (FDA) approved Levemir® (insulin detemir injection) for use in children ages 2 to 5 years with type 1 diabetes. Source: FDA website.
New Indications 05-22-12
Absorica
The Food and Drug Administration (FDA) approved AbsoricaTM (isotretinoin capsules) for the treatment of severe recalcitrant nodular acne. Source: FDA website.
New Formulation 05-27-12
Suprax
The Food and Drug Administration (FDA) approved Suprax®(cefixime 400 mg capsules) in the treatment of susceptible infections. Source: FDA website.
New Formulation 06-05-12
Horizant
The Food and Drug Administration (FDA) approved Horizant® (gabapentin enacarbil extended-release tablets) for the management of postherpetic neuralgia (PHN) in adults. Source: FDA website.
New Indications 06-07-12
Adderall
The Food and Drug Administration (FDA) is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceuticals Adderall® (amphetamine mixed salts 30 mg tablet) that is being purchased on the internet. The agency's preliminary tests revealed that this counterfeit version contained the wrong active ingredients. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306041.htm Source: FDA website.
Drug Warning 05-30-12
Introvale
Sandoz issued a voluntary recall of 10 lots of Introvale® (levonorgestrel/ethinyl estradiol), its generic oral contraceptive, due to reports of a packaging flaw. Contact your healthcare professionals with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm307103.htm Source: FDA website.
Drug Recall 06-06-12
Perjeta
The Food and Drug Administration (FDA) approved PerjetaTM (pertuzumab injection) for use in combination with trastuzumab and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Source: FDA website.
New Drug 06-08-12
MenHibrix
The Food and Drug Administration (FDA) approved MenHibrix® (Meningococcal Groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine) to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b in children aged six weeks through 18 months. Source: FDA website.
New Drug 06-15-12
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules) for the management of neuropathic pain associated with spinal cord injury. Source: FDA website.
New Indication 06-21-12
Gammagard Liquid
The Food and Drug Administration (FDA) approved Gammagard LiquidTM (immune globulin 10% for infusion) for the treatment of multifocal motor neuropathy (MMN). Source: FDA website.
New Indication 06-25-12
Cefepime
The Food and Drug Administration (FDA) reported cases of nonconvulsive status epilepticus seizures associated with the use of cefepime injection, primarily in individuals with renal impairment who did not receive appropriate dosage adjustments. The product labeling will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm309822.htm Source: FDA website.
Drug Warning 06-26-12
Belviq
The Food and Drug Administration (FDA) approved Belviq® (lorcaserin tablets) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes). Source: FDA website.
New Drug 06-27-12
Myrbetriq
The Food and Drug Administration (FDA) approved MyrbetriqTM (mirabegron extended release tablets) for the treatment of overactive bladder. Source: FDA website.
New Drug 06-28-12
Erbitux
Erbitux® (cetuximab) was approved by the Food and Drug Administration for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) for first-line treatment of individuals with K-ras mutation-negative (wild-type), epidermal growth factor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests. Source: FDA website.
New Indication 07-06-12
Vecuronium bromide
Bedford Laboratories announced a recall of one lot of vecuronium bromide injection 20 mg vial due to the discovery of particulate matter in a small number of vials. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310210.htm Source: FDA website.
Drug Recall 06-29-12
Leucovorin calcium
Bedford Laboratories announced a recall of three lots of leucovorin calcium injection due to the presence of visible particulate matter in a small number of vials. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310782.htm Source: FDA website.
Drug Recall 07-06-12
Zofran
The Food and Drug Administration (FDA) announced preliminary results from a clinical trial suggesting that a 32 mg single intravenous dose of Zofran® (ondansetron) may affect the electrical activity of the heart leading to an abnormal and potentially fatal heart rhythm. The drug label will be updated including removal of the 32 mg single dose. No single intravenous dose should exceed 16 mg. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310219.htm Source: FDA website.
Drug Warning 06-29-12
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) in combination with safer sex practices, to reduce the risk of sexually acquired human immunodeficiency virus (HIV)-1 infection in adults at high risk. Source: FDA website.
New Indication 07-16-12
Prepopik
The Food and Drug Administration (FDA) approved PrepopikTM (sodium picosulate/magnesium oxide/anhydrous citric acid powder for oral solution) for cleansing of the colon as a preparation for colonoscopy in adults. Source: FDA website.
New Drug 07-17-12
Qsymia
The Food and Drug Administration (FDA) approved QsymiaTM (phentermine/ topiramate) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults. Used in those with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes or dyslipidemia. Source: FDA website.
New Drug 07-18-12
Kyprolis
The Food and Drug Administration (FDA) approved KyprolisTM (carfilzomib injection) for the treatment of multiple myeloma. Source: FDA website.
New Drug 07-20-12
Afinitor
The Food and Drug Administration (FDA) approved Afinitor® (everolimus tablets) for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. Source: FDA website.
New Indication 07-20-12
Tudorza Pressair
The Food and Drug Administration (FDA) approved TudorzaTM PressairTM (aclidinium bromide oral inhalation) for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Source: FDA website.
New Drug 07-23-12
Rayos
The Food and Drug Administration (FDA) approved Rayos® (prednisone delayed-release) for the treatment of rheumatoid arthritis (RA). Source: FDA website.
New Drug 07-26-12
Vascepa
The Food and Drug Administration (FDA) approved VascepaTM (icosapent ethyl capsules) for the treatment of very high triglycerides. Source: FDA website.
New Drug 07-26-12
Ampyra
The Food and Drug Administration (FDA) communicated to healthcare professionals and the public about the risk of seizures in individuals with multiple sclerosis who are starting Ampyra® (dalfampridine). The majority of reported seizures occurred within days to weeks after starting the recommended dose in individuals having no history of seizures. The drug label will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm313055.htm Source: FDA website.
Drug Warning 07-23-12
Hospira injectable drug products
Hospira and the FDA announced a recall of certain injectable drug products due to visible particles embedded in the glass located at the neck of the vial. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm312048.htm Source: FDA website.
Drug Recall 07-16-12
Zaltrap
The Food and Drug Administration (FDA) approved Zaltrap® (ziv-aflibercept injection) for individuals with colorectal cancer who have failed previous treatment. Source: FDA website
New Drug 08-03-12
Marqibo
The Food and Drug Administration (FDA) approved Marqibo® (vincristine sulfate liposome injection) for treatment of adults with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more therapies. Source: FDA website
New Drug 08-09-12
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of diabetic macular edema (DME). Source: FDA website
New Indication 08-10-12
Auvi-Q Auto-Injector
The Food and Drug Administration (FDA) approved Auvi-Q® Auto-Injector (epinephrine injection) for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Auvi-Q has audio and visual cues to guide patients and caregivers through the injection process. Source: FDA website
New Drug 08-10-12
Codeine
The Food and Drug Administration (FDA) is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. The children had evidence of an inherited ability to convert codeine into life-threatening amounts of morphine. All children had received doses of codeine within the usual dose range. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315627.htm Source: FDA website
Drug Warning 08-15-12
Tradjenta
The Food and Drug Administration (FDA) approved Tradjenta® (linagliptin tablets) for add-on therapy to insulin in adults with type 2 diabetes. Source: FDA website
New Indications 08-17-12
Aplenzin
The Food and Drug Administration (FDA) approved AplenzinTM (bupropion hydrobromide extended-release tablets) for the prevention of seasonal major depressive episodes in individuals with seasonal affective disorder (SAD). Source: FDA website
New Indications 08-21-12
Stribild
The Food and Drug Administration (FDA) approved StribildTM (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate tablets) for once daily treatment of human immunodeficiency virus (HIV)-1 infection in treatment-naïve adults. Source: FDA website
New Drug 08-28-12
Nucynta ER
The Food and Drug Administration (FDA) approved Nucynta® ER (tapentadol extended-release tablets) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. Source: FDA website
New Indications 08-29-12
Afinitor Disperz
The Food and Drug Administration (FDA) approved Afinitor Disperz® (everolimus for oral suspension) for treatment of tuberous sclerosis complex (TSC) in individuals aged >1 year who are diagnosed with subependymal giant cell astrocytoma (SEGA) that cannot be treated with surgery. Source: FDA website
New Drug 08-29-12
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsule) for the treatment of men with metastatic castration-resistant prostate cancer previously treated with docetaxel. Source: FDA website
New Drug 08-31-12
Linzess
The Food and Drug Administration (FDA) approved LinzessTM (linaclotide capsules) for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. Source: FDA website
New Drug 08-30-12
Bosulif
The Food and Drug Administration (FDA) approved Bosulif® (bosutinib tablets) for previously treated chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML). Source: FDA website
New Drug 09-04-12
Aubagio
The Food and Drug Administration (FDA) approved Aubagio® (teriflunomide tablets) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website
New Drug 09-12-12
Revatio
The Food and Drug Administration (FDA) announced that Revatio® (sildenafil) should not be prescribed to children ages 1 through 17 for pulmonary arterial hypertension (PAH). Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317743.htm Source: FDA website
Drug Warning 08-30-12
Nimodipine
Sun Pharmaceutical Industries recalled one lot of nimodipine capsules 30 mg marketed by Caraco Pharmaceutical Laboratories due to crystallization of the fill material in the capsule. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm318207.htm Source: FDA website
Drug Recall 09-05-12
Hydrocodone bitartrate and Acetaminophen
Qualitest recalled one lot of hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg due to the potential for oversized tablets with a higher dosage of acetaminophen. Contact your health care professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm319058.htm Source: FDA website
Drug Recall 09-12-12
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of macular edema following central retinal vein occlusion. Source: FDA website
New Indications 09-21-12
Sorilux
The Food and Drug Administration (FDA) approved SoriluxTM (calcipotriene foam) for the topical treatment of plaque psoriasis of the scalp. Source: FDA website
New Indications 09-28-12
Aerospan
The Food and Drug Administration (FDA) approved Aerospan® (flunisolide HFA inhalation aerosol) for the maintenance treatment of asthma as a prophylactic therapy in adults and pediatric individuals 6 years and older. Source: FDA website
New Indications 09-20-12
Stivarga
The Food and Drug Administration (FDA) approved Stivarga® (regorafenib tablets) for the treatment of metastatic colon cancer in previously treated individuals. Source: FDA website
New Drug 09-27-12
Stivarga
The Food and Drug Administration (FDA) approved Stivarga® (regorafenib tablets) for the treatment of metastatic colon cancer in previously treated individuals. Source: FDA website
Drug Warning 09-19-12
Mirapex
The Food and Drug Administration (FDA) notified healthcare professionals of a possible increased risk of heart failure with Mirapex® (pramipexole). Further review of the data needed and the FDA will provide an update when available. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm320054.htm Source:FDA website
Drug Warning 09-19-12
Hydrocodone bitartrate and Acetaminophen
Watson Laboratories recalled two lots of hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg due to the potential for oversized tablets with a higher dosage of the active ingredients. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm320610.htm Source: FDA website
Drug Warning 09-24-12
Humira
The Food and Drug Administration (FDA) approved Humira®(adalimumab injection) to treat moderate-to-severe ulcerative colitis (UC) in individuals who are unresponsive to other therapies. Source: FDA website
New Indications 09-28-12
Quillivant XR
The Food and Drug Administration (FDA) approved Quillivant XRTM (methylphenidate hydrochloride extended-release oral suspension) for the treatment of attention deficit hyperactivity disorder (ADHD). Source: FDA website
New Formulation 10-01-12
Cystaran
The Food and Drug Administration (FDA) approved CystaranTM (cysteamine ophthalmic solution) for the treatment of corneal cystine crystal accumulation in individuals with cystinosis. Source: FDA website
New Formulation 10-02-12
Abraxane
The Food and Drug Administration (FDA) approved Abraxane® (albumin bound paclitaxel injection) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in individuals who are not candidates for curative surgery or radiation therapy. Source: FDA website
New Indications 10-12-12
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab injection) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Source: FDA website
New Indications 10-12-12
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) for the maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer that has progressed after platinum-based first-line chemotherapy. Source: FDA website
New Indications 10-18-12
Jetrea
The Food and Drug Administration (FDA) approved Jetrea® (ocriplasmin injection) for the treatment of symptomatic vitreomacular adhesion (VMA). Source: FDA website
New Drug 10-18-12
Oxtellar XR
The Food and Drug Administration (FDA) approved Oxtellar® XR (oxcarbazepine extended-release tablets) for use as adjunctive therapy in the treatment of partial seizures in adults and children 6-17 years of age. Source: FDA website
New Formulation 10-22-12
Pliaglis
The Food and Drug Administration (FDA) approved Pliaglis® (lidocaine/tetracaine cream) for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures. Source: FDA website
New Formulation 10-22-12
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets) for use as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in individuals with epilepsy who are 12 year old or older. Source: FDA website
New Drug 10-23-12
Lactated Ringer's and 5% Dextrose
The Food and Drug Administration (FDA) and Hospira announced a voluntary recall on one lot of Lactated Ringer's and 5% Dextrose Injection, 1000 mL Flexible Container due to possible mold contamination. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322966.htm Source: FDA website
Drug Warning 10-06-12
New England Compounding Center
The Food and Drug Administration (FDA) observed fungal contamination in a sealed vial of methylprednisolone acetate injection from the New England Compounding Center (NECC). The contaminated product has been linked to a fungal meningitis outbreak. The Centers for Disease Control and Prevention (CDC) and the FDA recommended that all health care professionals stop using and remove from their inventories any product made by the NECC. Fungus has been confirmed in additional unopened vials of methylprednisolone acetate injection from the NECC. As a result of the ongoing investigation, possible meningitis associated with triamcinolone acetonide has also been identified. Contact your healthcare professional with any questions. The latest details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm
Drug Warning 10-05-12
Ameridose
The Food and Drug Administration (FDA) announced that Ameridose, LLC is voluntarily recalling all of its unexpired products in circulation. The FDA is currently conducting an inspection of the Ameridose facility. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326370.htm Source: FDA website
Drug Recall 10-31-12
Over-the-Counter Eye Drops and Nasal Sprays
The Food and Administration (FDA) is warning healthcare professionals and consumers that accidental ingestion by children of certain over-the-counter (OTC) eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325729.htm Source: FDA website
Drug Warning 10-25-12
Pradaxa
The Food and Administration (FDA) evaluated new information about the risk of serious bleeding associated with the use of the blood thinners Pradaxa and warfarin. The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from a large clinical trial. The FDA is continuing to evaluate data. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm Source: FDA website
Drug Warning 11-02-12
Synribo
The Food and Drug Administration (FDA) approved SynriboTM (omacetaxine mepesuccinate injection) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to at least two tyrosine kinase inhibitors Source: FDA website
New Drug 10-26-12
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) for the treatment of rheumatoid arthritis (RA) after an inadequate response or intolerance to methotrexate. Source: FDA website
New Drug 11-06-12
Taclonex Topical Suspension
The Food and Drug Administration (FDA) approved Taclonex® Topical Suspension (calcipotriene/betamethasone dipropionate) for the treatment of body plaque psoriasis for up to 8 weeks in patients 18 years and older. Source: FDA website
New Indications 10-26-12
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment. Source: FDA website
New Indications 11-05-12
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) for the treatment of thrombocytopenia in individuals with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Source: FDA website
New Indications 11-19-12
Flucelvax
The Food and Drug Administration (FDA) approved Flucelvax®(inactivated influenza vaccine types A and B) for active immunization in the prevention of influenza in individuals 18 years old and older. This vaccine is an alternative to the traditional egg-based production formulation. Source: FDA website
New Drug 11-21-12
Cometriq
The Food and Drug Administration (FDA) approved CometriqTM (cabozantinib capsules) for the treatment of medullary thyroid cancer. Source: FDA website
New Drug 11-29-12
Zytiga
The Food and Drug Administration (FDA) approved Zytiga® (abiraterone acetate tablets) in combination with prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC) before the use of chemotherapy. Source: FDA website
New Indications 12-10-12
Rescula
The Food and Drug Administration (FDA) approved Rescula® (unoprostone isopropyl ophthalmic solution) for the lowering of intraocular pressure in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Indications 12-12-12
Iclusig
The Food and Drug Administration (FDA) approved IclusigTM (ponatinib tablets) for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy. Source: FDA website
New Drug 12-14-12
Atorvastatin
Ranbaxy announced a voluntary recall of 41 lots of atorvastatin calcium 10 mg, 20 mg, and 40 mg tablets. These lots may contain very small glass particles. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm329955.htm Source: FDA website
Drug Recall 11-28-12
Hydrocodone bitartrate/ acetaminophen
Qualitest announced a voluntary recall for 101 lots of hydrocodone bitartrate/acetaminophen 10 mg/500 mg tablets. Bottles from affected lots may contain tablets that have a higher dosage of acetaminophen. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331224.htm Source: FDA website
Drug Recall 12-07-12
Chantix
The Food and Drug Administration (FDA) announced the results of a large analysis of clinical trials that compared individuals who received the smoking cessation drug Chantix® (varenicline tablets) to those who received placebo. A higher incidence of major adverse cardiovascular events was seen in the Chantix group. It is uncertain whether the higher risk was due to the drug or chance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331626.htm Source: FDA website
Drug Recall 12-12-12
Signifor
The Food and Drug Administration (FDA) approved Signifor® (pasireotide injection) for the treatment of adults with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Source: FDA website
New Drug 12-14-12
ABthrax
The Food and Drug Administration (FDA) approved ABthraxTM (raxibacumab injection) for the treatment of adults and children with inhalational anthrax (due to Bacillus anthracis) in combination with appropriate antibacterial drugs and for prophylaxis when alternative therapies are not available or are not appropriate. Source: FDA website
New Drug 12-14-12
Xyrem
The Food and Drug Administration (FDA) reminded healthcare professionals and consumers that the combined use of Xyrem® (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (e.g., loss of consciousness, coma, or death). Product labeling will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332430.htm Source: FDA website
Drug Warning 12-17-12
Zofran
The Food and Drug Administration (FDA) is notifying healthcare professionals that the 32 mg single intravenous dose of the anti-nausea drug Zofran® (ondansetron hydrochloride) will no longer be marketed due to the potential for serious cardiac risks. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330772.htm Source: FDA website
Drug Warning 12-04-12
Fluarix Quadrivalent
The Food and Drug Administration (FDA) approved Fluarix® Quadrivalent (influenza vaccine) for the immunization of adults and children 3 years of age and older to prevent disease caused by seasonal influenza virus subtypes A and B. Source: FDA website
New Drug 12-17-12
Bivigam
The Food and Drug Administration (FDA) approved BivigamTM (immune globulin intravenous 10% liquid injection) for treatment of primary humoral immunodeficiency. This is a latex and sugar-free formulation. Source: FDA website
New Drug 12-19-12
Gattex
The Food and Drug Administration (FDA) approved Gattex® (teduglutide injection) for the treatment of adults with short bowel syndrome who are dependent on parenteral support. Source: FDA website
New Drug 12-21-12
Tamiflu
The Food and Drug Administration (FDA) expanded the Tamiflu® (oseltamivir) approval for the treatment of acute, uncomplicated influenza to include infants 2 weeks and older. Source: FDA website
New Indications 12-21-12
Adasuve
The Food and Drug Administration (FDA) approved AdasuveTM (loxapine inhalation powder) for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults. Source: FDA website
New Drug 12-26-12
VariZIG
The Food and Drug Administration (FDA) approved VariZIG® (varicella zoster immune globulin injection) for reducing the severity of chicken pox infections in high-risk individuals when given within four days after exposure. Source: FDA website
New Drug 12-26-12
Juxtapid
The Food and Drug Administration (FDA) approved JuxtapidTM (lomitapide capsules) for the adjunct treatment of homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering therapies. Source: FDA website
New Drug 12-21-12
Sirturo
The Food and Drug Administration (FDA) approved SirturoTM (bedaquiline tablets) for the treatment of pulmonary multi-drug resistant tuberculosis as part of combination therapy in adults. Source: FDA website
New Drug 12-31-12
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) to reduce the risk of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation. Source: FDA website
New Drug 12-28-12
Fulyzaq
The Food and Drug Administration (FDA) approved FulyzaqTM (crofelemer delayed-release tablets) for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on anti-retroviral therapy. Source: FDA website
New Drug 12-31-12
Rebif Rebidose
The Food and Drug Administration (FDA) approved Rebif® Rebidose® (interferon beta-1a injection) for self-administration of interferon beta-1a for treatment of relapsing forms of multiple sclerosis (MS). It is a single-use auto-injector. Source: FDA websitee
New Drug 01-03-13
Sklya
The Food and Drug Administration (FDA) approved SkylaTM (levonorgestrel intrauterine device) for prevention of pregnancy. Source: FDA website
New Drug 01-09-13
Incivek
The Food and Drug Administration (FDA) received reports of serious skin reactions, sometimes fatal, in individuals taking IncivekTM (telaprevir tablets) in combination with peginterferon alfa and ribavirin. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332860.htm Source: FDA website
Drug Warning 12-19-12
Pradaxa
The Food and Drug Administration (FDA) communicated that Pradaxa® (dabigatran etexilate mesylate capsules) should not be used to prevent stroke or blood clots in individuals with mechanical heart valves due to an increased risk of adverse cardiovascular events and bleeding. A contraindication will be added to product labeling. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332949.htm Source: FDA website
Drug Warning 12-19-12
Zolpidem
The Food and Drug Administration (FDA) announced their recommendation that the bedtime dose of zolpidem containing agents for insomnia be lowered due to new data showing that blood levels in some individuals may be high enough the morning after use to impair activities that require alertness. The FDA continues to evaluate the risk of impaired mental alertness with other drugs used for insomnia. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm Source: FDA website
Drug Warning 01-10-13
Ferrous sulfate labeled as Rugby National Iron Supplement
Advance Pharmaceutical Inc. announced a recall of one lot of ferrous sulfate 325 mg tablets after notification by a pharmacist that a bottle contained meclizine HCL 25 mg tablets. Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336137.htm Source: FDA website
Drug Recall 01-18-13
Samsca
The Food and Drug Administration (FDA) and the manufacturer announced reports of significant liver injury associated with the use of SamscaTM (tolvaptan tablets), a drug approved for the treatment of hyponatremia. Three subjects in a clinical trial developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336669.htm Source: FDA website
Drug Warning 01-25-13
Uceris
The Food and Drug Administration (FDA) approved UcerisTM (budesonide extended-release tablets) for the induction of remission in individuals with active, mild-to- moderate ulcerative colitis. Source: FDA website
New Drug 01-14-13
Flublok
The Food and Drug Administration (FDA) approved Flublok® (influenza virus vaccine injection) for the prevention of seasonal influenza in people 18 through 49 years of age. This is a trivalent vaccine made using an insect virus expression system and recombinant DNA technology. Source: FDA website
New Drug 01-16-13
Zecuity
The Food and Drug Administration (FDA) approved ZecuityTM (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan through the skin. Source: FDA website
New Drug 01-18-13
Gablofen
The Food and Drug Administration (FDA) approved Gablofen® (baclofen injection prefilled syringes) for severe spasticity to reduce preparation steps and simplify the pump refill process for individuals receiving ITB Therapy (intrathecal baclofen therapy). Source: FDA website
New Drug 01-22-13
Kineret
The Food and Drug Administration (FDA) approved Kineret® (anakinra injection) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). This is the most severe form of cryopyrin associated periodic syndromes (CAPS). Source: FDA website
New Indications 12-21-12
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of adults with overactive bladder who cannot tolerate or were not responsive to other agents for this condition. Source: FDA website
New Indications 01-18-13
Exjade
The Food and Drug Administration (FDA) approved Exjade® (deferasirox tablets for oral suspension) for the treatment of chronic iron overload in individuals aged 10 years or older with non-transfusion-dependent thalassemia (NTDT) syndromes. Source: FDA website
New Indications 01-23-13
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy as second-line treatment for individuals with metastatic colorectal cancer (mCRC) whose cancer has progressed on a first-line Avastin-containing regimen. Source: FDA website
New Indications 01-24-13
Prevnar
The Food and Drug Administration (FDA) expanded the use of Prevnar 13® (pneumococcal vaccine injection) to prevent infections with pneumococcal bacteria for children and adolescents aged 6 to 17 years. Source: FDA website
New Indications 01-25-13
Gleevec
The Food and Drug Administration (FDA) approved Gleevec® (imatinib tablets) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Source: FDA website
New Indications 01-25-13
Nesina
The Food and Drug Administration (FDA) approved NesinaTM (alogliptin tablets) as an adjunct to diet and exercise to improve glucose control in adults with type 2 diabetes. Source: FDA website
New Drug 01-25-13
Kazano
The Food and Drug Administration (FDA) approved KazanoTM (alogliptin/metformin tablets) as an adjunct to diet and exercise to improve glucose control in adults with type 2 diabetes. Source: FDA website
New Drug 01-25-13
Oseni
The Food and Drug Administration (FDA) approved OseniTM (alogliptin/pioglitazone tablets) as an adjunct to diet and exercise to improve glucose control in adults with type 2 diabetes. Source: FDA website
New Drug 01-25-13
Kynamro
The Food and Drug Administration (FDA) approved KynamroTM (mipomersen injection) as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in individuals with homozygous familial hypercholesterolemia (HoFH). Source: FDA website
New Drug 01-29-13
Ravicti
The Food and Drug Administration (FDA) approved RavictiTM (glycerol phenylbutyrate oral liquid) for the chronic management of adults and children 2 years and older with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Source: FDA website
New Drug 02-01-13
Delzicol
The Food and Drug Administration (FDA) approved Delzicol® (mesalamine delayed-release capsules) for the treatment of ulcerative colitis. Source: FDA website
New Drug 02-01-13
Vistide
Gilead Sciences voluntarily recalled one lot of Vistide® (cidofovir injection) due to the presence of particulate matter found in some vials of this lot. Contact your healthcare professional with any questions. Details may be found at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340094.htm Source: FDA website
Drug Recall 02-16-13
Omontys
The Food and Drug Administration (FDA) and the manufacturers of Omontys® (peginesatide injection) announced a voluntary recall of all lots of Omontys due to new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340895.htm Source: FDA website
Drug Recall 02-23-13
Codeine-containing products
The Food and Drug Administration (FDA) announced new actions being taken to address safety concerns with codeine use in certain children after tonsillectomy and/or adenoidectomy. Product labeling for codeine-containing products will be updated. Contact your healthcare professional with any questions. Details may be found at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315627.htm Source: FDA website
Drug Warning 02-20-13
Sensipar
The Food and Drug Administration (FDA) has stopped all pediatric clinical trials of SensiparTM (cinacalcet hydrochloride tablets) after the death of a 14-year-old subject in a trial. It has not been determined if the death was related to Sensipar. Available information is still being evaluated. Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm341255.htm Source: FDA website
Drug Warning 02-26-13
Pomalyst
The Food and Drug Administration (FDA) approved Pomalyst® (pomalidomide capsules) for the treatment of relapsed and refractory multiple myeloma. Source: FDA website
New Drug 02-08-13
Kadcyla
The Food and Drug Administration (FDA) approved KadcylaTM (ado-trastuzumab emtansine injection) for the treatment of HER2-positive breast cancer in individuals who have received prior treatment with Herceptin® (trastuzumab injection) and a taxane chemotherapy. Source: FDA website.
New Drug 02-22-13
Osphena
The Food and Drug Administration (FDA) approved OsphenaTM (ospemifene tablets) for the treatment of women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. Source: FDA website.
New Drug 02-26-13
Zortress
The Food and Drug Administration (FDA) approved ZortressTM (everolimus tablets) for organ rejection prophylaxis in adults receiving a liver transplant. Source: FDA website
New Indications 02-19-13
Epiduo Gel
The Food and Drug Administration (FDA) approved Epiduo® Gel (adapalene/benzoyl peroxide gel) for the treatment of acne in children as young as 9 years old. Source: FDA website
New Indications 02-19-13
Stivarga
The Food and Drug Administration (FDA) approved Stivarga® (regorafenib tablets) for the treatment of advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to Gleevec® (imatinib tablets) and Sutent® (sunitinib capsules). Source: FDA website
New Indications 02-25-13
Abilify Maintena
The Food and Drug Administration (FDA) approved Abilify MaintenaTM (aripiprazole extended-release injectable suspension) for the once-monthly treatment of schizophrenia. Source: FDA website.
New Drug 02-28-13
Vituz
The Food and Drug Administration (FDA) approved Vituz® (hydrocodone bitartrate/chlorpheniramine maleate oral solution) for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Source: FDA website
New Drug 02-20-13
TOBI Podhaler
The Food and Drug Administration (FDA) approved TOBI® PodhalerTM (tobramycin inhalation powder) for the management of individuals with cystic fibrosis (CF) who have Pseudomonas aeruginosa (Pa) bacteria in the lungs. Source: FDA website
New Drug 03-22-13
Tecfidera
The Food and Drug Administration (FDA) approved TecfideraTM (dimethyl fumarate delayed-release capsules) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website
New Drug 03-27-13
Aciphex Sprinkle
The Food and Drug Administration (FDA) approved Aciphex® SprinkleTM (rabeprazole delayed-release capsules) for the treatment of gastroesophageal reflux disease (GERD) in children 1-11 years of age for up to 12 weeks. The granule contents are sprinkled on a small amount of soft food or into a small amount of liquid. Source: FDA website
New Drug 03-27-13
Quartette
The Food and Drug Administration (FDA) approved QuartetteTM (levonorgestrel/ethinyl estradiol tablets) for the prevention of pregnancy. This is an extended regimen designed to minimize breakthrough bleeding. Source: FDA website
New Drug 03-29-13
Invokana
The Food and Drug Administration (FDA) approved InvokanaTM (canagliflozin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug 03-29-13
Karbinal ER
The Food and Drug Administration (FDA) approved KarbinalTM ER (carbinoxamine maleate extended-release oral suspension) for the treatment of seasonal and perennial allergic rhinitis in children 2 years or older. Source: FDA website
New Drug 04-03-13
Prolensa
The Food and Drug Administration (FDA) approved once daily ProlensaTM (bromfenac ophthalmic solution) for the treatment of post-operative inflammation and reduction of ocular pain in individuals who have undergone cataract surgery. Source: FDA website
New Drug 04-08-13
Diclegis
The Food and Drug Administration (FDA) approved Diclegis® (doxylamine succinate/pyridoxine hydrochloride delayed-release tablets) for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. Source: FDA website
New Drug 04-08-13
Bivigam
The Food and Drug Administration (FDA) announced that visible particles were observed in one lot of BivigamTM immune globulin intravenous, 10% liquid. Biotest is voluntarily recalling this lot from the market. Contact your healthcare professional with any questions. More details including the affected lot number may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346771.htm Source: FDA website
Drug Warning 04-05-13
Azithromycin
The Food and Drug Administration (FDA) is warning that azithromycin (Zithromax® or ZmaxTM) can cause abnormal changes in the electrical activity of the heart that may lead to potentially fatal irregular heart rhythms. Individuals with known risk factors are at particular risk. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343350.htm Source: FDA website
Drug Warning 03-12-13
Clinical Specialties Compounding Pharmacy
Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344831.htm Source: FDA website
Drug Warning 03-21-13
Incretin mimetic drugs
The Food and Drug Administration (FDA) is evaluating unpublished data that suggest an increased risk of pancreatitis and pre-cancerous cellular changes in individuals with type 2 diabetes treated with incretin mimetics (exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin, and linagliptin). The FDA will communicate its conclusions and recommendations. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm Source: FDA website
Drug Warning 03-14-13
Pallimed Solutions, Inc.
Pallimed Solutions, Inc., doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compounded products dispensed since January 1, 2013. Recent inspections found visible particulates in vials of several different sterile compounded products. Products were distributed directly to consumers and/or physicians. Contact your healthcare professional with any questions. More details including affected products may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm345477.htm Source: FDA website
Drug Warning 03-27-13
Amitiza
The Food and Drug Administration (FDA) approved Amitiza® (lubiprostone capsules) for the treatment of opioid-induced constipation in individuals with chronic non-cancer pain. Source: FDA website
New Indications 04-19-13
Sitavig
The Food and Drug Administration (FDA) approved Sitavig® (acyclovir mucoadhesive tablet) for the treatment of recurring Herpes labialis. Source: FDA website
New Drug 04-12-13
Suclear
The Food and Drug Administration (FDA) approved SuclearTM (sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride oral solution) for cleansing of the colon in preparation for colonoscopy in adults. Source: FDA website
New Drug 01-18-13
Minastrin 24 FE
The Food and Drug Administration (FDA) approved MinastrinTM 24 FE (norethindrone acetate and ethinyl estradiol capsules/ferrous fumarate capsules) for the prevention of pregnancy. Source: FDA website
New Drug 04-19-13
Simbrinza
The Food and Drug Administration (FDA) approved SimbrinzaTM (brinzolamide and brimonidine tartrate ophthalmic suspension) for the reduction of elevated intraocular pressure (IOP) in individuals with primary open-angle glaucoma or ocular hypertension. Source: FDA website
New Drug 04-19-13
Topicort Topical Spray
The Food and Drug Administration (FDA) approved Topicort® (desoximetasone topical spray) for the treatment of plaque psoriasis in patients 18 years of age and older. Source: FDA website
New Drug 04-11-13
OneTouch Verio IQ Blood Glucose Meter
LifeScan, Inc. and the FDA report that at extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch® Verio® IQ Meter will turn off instead of displaying a warning message as intended. When turned back on, the meter enters the set-up mode. All meters are being recalled and were distributed from December 14, 2011 through March 7, 2013. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349187.htm Source: FDA website
Drug Recall 04-23-13
ApotheCure, Inc.
ApotheCure, Inc. announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired due to lack of sterility assurance and concerns associated with the quality control processes. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348170.htm Source: FDA website
Drug Recall 04-16-13
NuVision Pharmacy
NuVision Pharmacy announced a voluntary recall of all unexpired lots of lyophilized compounds HcG 5000IU-5 mL and Sermorelin/GHRH6-5 mL due to a lack of sterility assurance and concerns associated with the quality control processes. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348156.htm Source: FDA website
Drug Recall 04-16-13
Green Valley Drugs
Green Valley Drugs announced a recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm347755.htm Source: FDA website
Drug Recall 04-11-13
Nora Apothecary & Alternative Therapies
Nora Apothecary & Alternative Therapies announced a voluntary recall of all unexpired sterile drug products compounded by the pharmacy due to concerns associated with quality control processes that present a lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349112.htm Source: FDA website
Drug Recall 04-23-13
Balanced Solutions
Balanced Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of all sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control processes. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348848.htm Source: FDA website
Drug Recall 04-22-13
Procysbi
The Food and Drug Administration (FDA) approved ProcysbiTM (cysteamine bitartrate capsule) for the management of nephropathic cystinosis in children and adults. Source: FDA website
New Drug 04-30-13
Liptruzet
The Food and Drug Administration (FDA) approved LiptruzetTM (ezetimibe/atorvastatin tablet) for the treatment of elevated low-density lipoprotein (LDL)-cholesterol in individuals with primary or mixed hyperlipidemia as an adjunct to dietary changes. Source: FDA website
New Drug 05-07-13
Xofigo
The Food and Drug Administration (FDA) approved XofigoTM (radium Ra 223 dichloride injection) for the treatment of symptomatic late-stage castration-resistant prostate cancer with bone metastases. Source: FDA website
New Drug 05-15-13
Kcentra
The Food and Drug Administration (FDA) approved KcentraTM (prothrombin complex concentrate injection) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Source: FDA website
New Drug 04-29-13
Nymalize
The Food and Drug Administration (FDA) approved NymalizeTM (nimodipine oral solution) to improve neurological outcome by reducing the incidence and severity of ischemic deficits in adults with subarachnoid hemorrhage (SAH). Source: FDA website
New Drug 05-14-13
Breo Ellipta
The Food and Drug Administration (FDA) approved BreoTM ElliptaTM (fluticasone furoate/vilanterol inhalation powder) for the maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug 05-10-13
Norethindrone acetate/ethinyl estradiol/ferrous fumarate chewable tablets
The Food and Drug Administration (FDA) approved norethindrone acetate/ethinyl estradiol/ferrous fumarate chewable tablets for the prevention of pregnancy. Brand name to be announced. Source: FDA website
New Drug 05-09-13
TriMix-gel
The Food and Drug Administration (FDA) approved TriMix-gel® (prostaglandin E/papaverine/phentolamine) for the treatment of erectile dysfunction for individuals who cannot tolerate self-injection or who have failed oral agents. Source: www.trimixgel.com
New Drug 05-07-13
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab injection) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children 2 years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX). Source: FDA website
New Indications 05-01-13
Vyvanse
The Food and Drug Administration (FDA) approved Vyvanse® (lisdexamfetamine dimesylate capsule) for the maintenance treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD). Source: FDA website
New Indications 04-26-13
Sustiva
The Food and Drug Administration (FDA) approved Sustiva® (efavirenz capsule) for the treatment of human immunodeficiency virus-1 (HIV)-1 infections in individuals three months to three years old and weighing at least 3.5 kg. The approval includes a once daily regimen option for this population and a capsule sprinkle administration method for individuals who cannot swallow capsules or tablets. Source: FDA website
New Indications 05-03-13
Ilaris
The Food and Drug Administration (FDA) approved Ilaris® (canakinumab injection) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in individuals aged 2 years and older. Source: FDA website
New Indications 05-10-13
Simponi
The Food and Drug Administration (FDA) approved Simponi® (golimumab injection) for the treatment of moderately to severely active ulcerative colitis (UC) in adults who have demonstrated corticosteroid dependence or who have had inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Source: FDA website
New Indications 05-16-13
Tarceva
The Food and Drug Administration (FDA) approved Tarceva® (erlotinib tablet) for the first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA approved test. The FDA also approved the Cobas® EGFR Mutation Test. Source: FDA website
New Indications 05-14-13
Samsca
The Food and Drug Administration (FDA) communicated that SamscaTM (tolvaptan tablet), approved for treatment of hyponatremia, should not be used for longer than 30 days and should not be used in individuals with underlying liver disease due to the potential for liver injury, transplant, or death. The drug labeling will be updated to include these new limitations. Contact your health professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350185.htm Source: FDA website
Drug Warning 04-30-13
Potiga
The Food and Drug Administration (FDA) announced that the anti-seizure medication PotigaTM (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. It is unclear if theses changes are reversible. The FDA will provide an update when more information is available. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349847.htm Source: FDA website
Drug Warning 04-26-13
Valproate containing products
The Food and Drug Administration (FDA) communicated that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, should not be taken by pregnant women for the prevention of migraine headaches. The labels for these medications will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm Source: FDA website
Drug Warning 05-06-13
Zolpidem containing products
The Food and Drug Administration (FDA) recommended that the bedtime dose of the insomnia drug zolpidem, including brand and generic products, be lowered due to new data showing blood levels may be high enough the morning after use to impair activities that require alertness. The labeling for these drugs will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm Source: FDA website
Drug Warning 05-14-13
The Compounding Shop
The Food and Drug Administration (FDA) communicated concerns regarding a lack of sterility assurance for sterile drugs produced at and distributed from The Compounding Shop of St. Petersburg, FL. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm
Drug Recall 05-08-13
Tafinlar
The Food and Drug Administration (FDA) approved Tafinlar® (dabrafenib) for the treatment of advanced or unresectable melanoma with BRAF V600E mutations. Source: FDA website
New Drug 05-29-13
Mekinist
The Food and Drug Administration (FDA) approved MekinistTM (trametinib) for the treatment of advanced or unresectable melanoma with BRAF V600E or V600K mutations. Source: FDA website
New Drug 05-29-13
Bloxiverz
The Food and Drug Administration (FDA) approved BloxiverzTM (neostigmine methylsulfate injection) for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Source: FDA website
New Drug 06-03-13
Fluzone Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® Quadrivalent (influenza vaccine injection) for use in children 6 months of age and older, adolescents, and adults during the 2013 influenza season. Source: FDA website
New Drug 06-07-13
Ixiaro
The Food and Drug Administration (FDA) approved Ixiaro® (Japanese encephalitis vaccine injection) for the prevention of Japanese encephalitis in children as young as 2 months old. Source: FDA website
New Indications 05-17-13
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) for the treatment of individuals with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Source: FDA website
New Indications 06-05-13
Xgeva
The Food and Drug Administration (FDA) approved XgevaTM (denosumab injection) for the treatment of adults and some adolescents with giant cell tumor of the bone (GCTB). Source: FDA website
New Indications 06-13-13
Main Street Pharmacy
The Main Street Family Pharmacy has announced a voluntary recall of all lots of sterile products compounded by the pharmacy. The products have a use by date on or before November 20, 2013. The recall is due to seven reported cases of skin abscesses. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353953.htm Source: FDA website
Drug Recall 05-28-13
Olympia Pharmacy
Olympia Pharmacy announced a voluntary recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is due to concerns with poor quality control procedures that impacted sterility assurance. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm354614.htm Source: FDA website
Drug Recall 05-30-13
Vecuronium bromide
Sagent Pharmaceuticals announced a voluntary recall of three lots of Vecuronium bromide for injection 10 mg. The recall is due to discovery of an elevated impurity result detected during routine quality testing. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm356050.htm Source: FDA website
Drug Recall 06-10-13
Warfarin
Zydus Pharmaceuticals announced a voluntary recall of one lot of Warfarin 2 mg tablets, expiration date June 2014 due to oversized tablets. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm356519.htm Source: FDA website
Drug Recall 06-12-13
Pentec Health, Inc.
Pentec Health, Inc announced a voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of it laminar flow hoods used in compounding. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352939.htm Source: FDA website
Drug Recall 05-17-13
NuVision Pharmacy
The Food and Drug Administration (FDA) is communicating concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. This is an expanded alert based on a recent inspection of the Dallas facility. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm Source: FDA website
Drug Recall 05-20-13
Methotrexate sodium
Sandoz announced a voluntary recall of two lots of Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injection due to the discovery of particulate matter in vials during a routine quality examination. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353266.htm Source: FDA website
Drug Recall 05-21-13
Magnesium sulfate injection
The Food and Drug Administration (FDA) is recommending against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. Administration for longer than 5-7 days may lead to low calcium levels and bone problems in the developing fetus. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm354603.htm Source: FDA website
Drug Warning 05-30-13
Zyprexa Relprevv
The Food and Drug Administration (FDA) is investigating two unexplained deaths in individuals who received an intramuscular injection of the antipsychotic drug Zyprexa® RelprevvTM (olanzapine pamoate injection). Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm357601.htm Source: FDA website
Drug Warning 05-30-13
Vibativ
The Food and Drug Administration (FDA) approved VibativTM (telavancin injection) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Source: FDA website
New Indications 06-21-13
Mycamine
The Food and Drug Administration (FDA) approved Mycamine® (micafungin sodium injection) for the treatment of pediatric individuals > 4 months with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in those undergoing hematopoietic stem cell transplants (HSCT). Source: FDA website
New Indications 06-24-13
Exelon
The Food and Drug Administration (FDA) approved Exelon® 13.3 mg/24 h (rivastigmine transdermal system) to include the treatment of people with severe Alzheimer's disease. Source: FDA website
New Indications 06-28-13
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) to treat adults with major depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and adjunctive therapy with either lithium or valproate. Source: FDA website
New Indications 07-01-13
Brisdelle
The Food and Drug Administration (FDA) approved BrisdelleTM (paroxetine mesylate capsule) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Source: FDA website
New Drug 06-28-13
Zubsolv
The Food and Drug Administration (FDA) approved ZubsolvTM (buprenorphine/naloxone sublingual tablet) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug 07-04-13
Khedezla
The Food and Drug Administration (FDA) approved KhedezlaTM (desvenlafaxine extended-release tablets) for the treatment of major depressive disorder. Source: FDA website
New Drug 07-10-13
Gilotrif
The Food and Drug Administration (FDA) approved GilotrifTM (afatinib tablets) for the first-line (initial) treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR gene mutations as detected by an FDA-approved test. Source: FDA website
New Drug 07-12-13
Rixubis
The Food and Drug Administration (FDA) approved RixubisTM (coagulation factor IX recombinant injection) for the routine prevention, control of bleeding episodes, and perioperative management in adults with hemophilia B. Source: FDA website
New Drug 06-27-13
Simponi Aria
The Food and Drug Administration (FDA) approved Simponi® AriaTM (golimumab for infusion) for the treatment of moderately to severely active rheumatoid arthritis. Source: FDA website
New Drug 07-18-13
Estarylla
Sandoz announced a voluntary recall of one lot of EstaryllaTM (norgestimate/ethinyl estradiol tablets), an oral contraceptive, following a customer report of a placebo tablet present in a row of active tablets on one pack. Contact your healthcare professional with any concerns. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm359656.htm Source: FDA website
Drug Recall 07-05-13
Benztropine mesylate
Fresenius Kabi USA announced a voluntary recall of four lots of Benztropine mesylate injection 2 mg/2 mL in 2 mL single dose vials, used in Parkinsonism, due to the potential presence of glass particles in the vials. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm359330.htm Source: FDA website
Drug Recall 07-02-13
Recombivax HB
Merck Sharp & Dohme Corp announced a voluntary recall of Recombivax HB® (recombinant hepatitis B vaccine injection) due to the potential for a limited number of cracked vials to be present in one lot. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm359493.htm Source: FDA website
Drug Recall 07-03-13
Olmesartan medoxomil
The Food and Drug Administration (FDA) announced that the blood pressure drug olmesartan medoxomil (marketed as Benicar®, Benicar HCT®, Azor®, TribenzorTM, and generics) could cause intestinal problems known as sprue-like enteropathy. Symptoms include severe, chronic diarrhea with substantial weight loss. Labeling changes have been approved. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm359528.htm Source: FDA website
Drug Warning 07-03-13
Hydroxyethyl starch solutions
The Food and Drug Administration (FDA) analyzed recent data in individuals using hydroxyethyl starch solutions (HES) for hypovolemia. This data indicates an increased risk of mortality and severe renal injury in critically ill adults and excess bleeding particularly in individuals undergoing open-heart surgery with cardiopulmonary bypass. The FDA concluded that HES solutions should not be used in critically ill adults and labeling has been updated. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm358349.htm Source: FDA website
Drug Warning 06-24-13
Menveo
The Food and Drug Administration (FDA) approved Menveo® (meningococcal vaccine groups A C Y W-135 conjugate) for prevention of meningococcal disease in infants and toddlers from 2 months of age. Source: FDA website
New Indications 08-02-13
Fetzima
The Food and Drug Administration (FDA) approved FetzimaTM (levomilnacipran extended-release capsules) for the treatment of major depressive disorder (MDDD) in adults. Source: FDA website
New Drug 07-26-13
Injectafer
The Food and Drug Administration (FDA) approved Injectafer® (ferric carboxymaltose injection) for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Source: FDA website
New Drug 07-25-13
Tivicay
The Food and Drug Administration (FDA) approved Tivicay® (dolutegravir tablets) for the treatment of HIV-1 infection in combination with other antiretroviral drugs. Source: FDA website
New Drug 08-12-13
Astagraf XL
The Food and Drug Administration (FDA) approved Astagraf XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in adult kidney transplant recipients. Source: FDA website
New Drug 07-21-13
Lo Minastrin FE
The Food and Drug Administration (FDA) approved Lo Minastrin FETM (norethindrone acetate/ethinyl estradiol/ferrous fumarate tablets) for the prevention of pregnancy. Source: FDA website
New Drug 07-25-13
Onfi
The Food and Drug Administration (FDA) approved Onfi® (clobazam oral suspension) for the treatment of seizures associated with Lennox-Gastaut syndrome. Source: FDA website
New Drug 08-12-13
Epaned
The Food and Drug Administration (FDA) approved EpanedTM (enalapril maleate for oral solution) for the treatment of hypertension in individuals greater than 1 month old. Source: FDA website
New Drug 08-14-13
Valchlor
The Food and Drug Administration (FDA) approved ValchlorTM (mechlorethamine topical gel) for the treatment of early stage cutaneous T-cell lymphoma. Source: FDA website
New Drug 08-26-13
Esomeprazole strontium
The Food and Drug Administration (FDA) approved Esomeprazole strontium delayed-release capsule formulation for treatment of gastroesophageal reflux disease (GERD), risk reduction of non-steroidal anti-inflammatory drug (NSAID)-associated gastric ulcer, pathological hypersecretory conditions, and Helicobacter pylori eradication. Source: FDA website
New Drug 08-06-13
FluLaval Quadrivalent
The Food and Drug Administration (FDA) approved FluLaval® Quadrivalent (influenza virus vaccine) four strain influenza virus vaccine for the active immunization of individuals > 3 years of age to help prevent disease caused by seasonal influenza virus subtypes A and B. Source: FDA website
New Drug 08-16-13
Trokendi XR
The Food and Drug Administration (FDA) approved Trokendi XRTM (topiramate extended-release capsules) for the treatment of epilepsy. Source: FDA website
New Drug 08-19-13
Mirvaso
The Food and Drug Administration (FDA) approved Mirvaso® (brimonidine topical gel) for the treatment of persistent facial erythema associated with rosacea in adults 18 years or older. Source: FDA website
New Drug 08-26-13
Nova Max Glucose Test Strips
Nova Diabetes Care announced a recall of 21 lots of Nova MaxTM Glucose Test Strips. Nova Max Plus Glucose Meter Kits that include test strips from the recalled lots are also included in the recall. The affected strips may report a false, abnormally high blood glucose result. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362932.htm Source: FDA website
Drug Recall 07-29-13
Beacon Hill Medical Pharmacy/Rxtra Solutions
Beacon Hill Medical Pharmacy and the Food and Drug Administration (FDA) announced a recall of all lots of certain sterile products due to lack of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363460.htm Source: FDA website
Drug Recall 08-01-13
Benztropine mesylate
Nexus Pharmaceuticals announced a recall of two lots of Benztropine mesylate injection 2 mg/2 mL in 2 mL single dose vials due to the presence of visible particulate matter in the vials. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363741.htm Source: FDA website
Drug Recall 08-02-13
Specialty Compounding
Specialty Compounding announced a voluntary recall of all lots of unexpired sterile products due to reports of bacterial infection affecting individuals treated with products from Specialty Compounding. There is a potential association. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm364595.htm Source: FDA website
Drug Recall 08-09-13
NuVision Pharmacy
The Food and Drug Administration (FDA) is reminding health care providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The sterility of these products cannot be assured. NuVision Pharmacy has declined to recall its sterile products. Therefore, the agency is reminding health care providers not to use any sterile products from NuVision. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm Source: FDA website
Drug Recall 08-16-13
Aidapak Services
Aidapak Services, LLC announced a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in Washington, Oregon, California, and Arizona due to possible incorrect labeling. The products are listed on the company's website. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365417.htm Source: FDA website
Drug Recall 08-17-13
Nizoral
The Food and Drug Administration (FDA) reported that Nizoral® (ketoconazole tablets) can lead to potentially fatal liver injury, risk of drug interactions, and adrenal gland issues and should not be used as first line treatment of fungal infection. The FDA has approved labeling changes and a new Medication Guide. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362672.htm Source: FDA website
Drug Warning 07-26-13
Mefloquine hydrochloride
The Food and Drug Administration (FDA) announced strengthened and updated warnings regarding neurologic and psychiatric adverse effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning has been added to the drug label and the Medication Guide has been revised. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362887.htm Source: FDA website
Drug Warning 07-29-13
Fluoroquinolones
The Food and Administration (FDA) is requiring drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to describe the risk of peripheral neuropathy. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365302.htm Source: FDA website
Drug Warning 08-15-13
Acetaminophen
The Food and Drug Administration (FDA) announced that acetaminophen has been associated with a risk of rare but serious skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). These reactions can occur with first-time use of acetaminophen or at any time it is being taken. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363519.htm Source: FDA website
Drug Warning 08-01-13
Gilenya
The Food and Drug Administration (FDA) announced that an individual in Europe diagnosed with possible multiple sclerosis (MS) developed a rare brain infection, progressive multifocal leukoencephalopathy (PML), following the administration of Gilenya® (fingolimod capsule). The individual had not previously received Tysabri® (natalizumab injection), another MS drug associated with a higher risk of PML. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366751.htm Source: FDA website
Drug Warning 08-29-13
Motrin Infant Drops
McNeil Consumer Healthcare announced a voluntary recall of three lots of Concentrated Motrin® (ibuprofen drops) Infant Drops Original Berry Flavor due to the presence of particles found in a different product lot during manufacturing. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367597.htm Source: FDA website
Drug Recall 09-08-13
Carboxy-methylcellulose Sodium
Altaire Pharmaceuticals announced a voluntary recall of nine lots of over-the-counter (OTC) Carboxymethylcellulose Sodium 0.5% ophthalmic solution due to concerns regarding the effectiveness of the preservative. The product is used to relieve dryness of the eye and is sold under Walmart, CVS, and Target brands. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367598.htm Source: FDA website
Drug Recall 09-08-13
Leiter's Compounding Pharmacy
Leiter's Compounding Pharmacy announced a voluntary recall of three lots of sterile products due to concerns of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm368206.htm Source: FDA website
Drug Recall 09-12-13
Park Compounding
Park Compounding announced a voluntary recall of one lot of Testosterone Cypionate (sesame oil) 200 mg/mL for injection in 10 mL amber vials due to concerns of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367864.htm Source: FDA website
Drug Recall 09-10-13
Avella Specialty Pharmacy
Avella Specialty Pharmacy announced a voluntary recall of two compounded sterile medications, bevacizumab 1.25 mg/0.05 mL PF and vancomycin PF 1% due to concerns of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367719.htm Source: FDA website
Drug Recall 09-09-13
University Compounding Pharmacy
University Compounding Pharmacy announced a voluntary recall of products including Testosterone Cypionate (sesame oil), Testosterone Cypionate/Testosterone Propionate, and PGE-1 NS for injection due to lack of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367596.htm Source: FDA website
Drug Recall 09-08-13
Medaus Pharmacy
Medaus Pharmacy announced a voluntary recall of certain sterile compounded consumer products due to inability to confirm sterility of these products. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367421.htm Source: FDA website
Drug Recall 09-05-13
Abraxane
The Food and Drug Administration (FDA) approved Abraxane® (paclitaxel albumin-bound injection) for the treatment of late-stage pancreatic cancer. Source: FDA website
New Indications 09-06-13
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) to treat temporarily moderate-to-severe canthal lines, also known as crow's feet. Source: FDA website
New Indications 09-11-13
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) alone or combined with methotrexate for the treatment of active psoriatic arthritis in adults. Source: FDA website
New Indications 09-23-13
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of adults with active psoriatic arthritis. Source: FDA website
New Indications 09-30-13
Perjeta
The Food and Drug Administration (FDA) approved Perjeta® (pertuzumab injection) for treatment of early stage breast cancer before surgery (neoadjuvant setting). Source: FDA website
New Indications 09-30-13
Treanda
The Food and Drug Administration (FDA) approved Treanda® (bendamustine injection) liquid formulation for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. The new formulation does not need to be reconstituted prior to adding to the diluent and administering to the patient. Source: FDA website
New Drug 09-17-13
Kogenate FS
The Food and Drug Administration (FDA) approved Kogenate® FS (recombinant antihemophilic factor injection) with a vial adapter. This is a needleless reconstitution system for the control and prevention of bleeding episodes in hemophilia A. Source: FDA website
New Drug 10-03-13
Clinolipid
The Food and Drug Administration (FDA) approved Clinolipid (lipid emulsion injection) for parenteral nutrition in adults who are unable to eat or drink. Source: FDA website
New Drug 10-07-13
Brintellix
The Food and Drug Administration (FDA) approved BrintellixTM (vortioxetine tablet) for the treatment of adults with major depressive disorder. Source: FDA website
New Drug 09-30-13
Duavee
The Food and Drug Administration (FDA) approved DuaveeTM (bazedoxifene/conjugated estrogens tablet) for the treatment of moderate-to-severe symptoms of menopause and to prevent postmenopausal osteoporosis. Source: FDA website
New Drug 10-03-13
Adempas
The Food and Drug Administration (FDA) approved Adempas® (riociguat tablet) for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Source: FDA website
New Drug 10-08-13
Duragesic
The Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic® (fentanyl patch) for pain so they can be seen more easily. These changes are being made in an attempt to minimize the risk of accidental exposure to these patches. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369457.htm Source: FDA website
Drug Warnings 09-23-13
Arzerra and Rituxan
The Food and Drug Administration (FDA) approved changes to the prescribing information for Arzerra® (ofatumumab injection) and Rituxan® (rituximab injection) to add a Boxed Warning about the risk of reactivation of hepatitis B virus infection. Contact your healthcare professional with any questions. More details are available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369846.htm Source: FDA website
Drug Warnings 09-25-13
The Compounding Shop
The Food and Drug Administration (FDA) announced that budesonide solution for nasal irrigation from The Compounding Shop may be contaminated and should not be used. Contact your healthcare professional with any questions. More details may be available at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm351326.htm Source: FDA website
Drug Warnings 09-27-13
Metoclopramide and Ondansetron
Hospira announced a voluntary recall of one lot of Metoclopramide injection and two lots of Ondansetron injection due to the presence of glass particulate matter inside the vial walls. Contact your healthcare professional with any questions. More details may be available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370663.htm Source: FDA website
Drug Recall 10-02-13
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of adults with active ankylosing spondylitis. Source: FDA website
New Indications 10-18-13
Sabril
The Food and Drug Administration (FDA) approved Sabril® (vigabatrin oral solution) as add-on therapy for the treatment of refractory complex partial seizures in children 10 years of age and older with inadequate response to other treatments and if the possible benefit outweighs the risk of vision loss. Source: FDA website
New Indications 10-28-13
Entereg
The Food and Drug Administration (FDA) approved the use of Entereg® (alvimopan capsules) to accelerate the time to upper and lower gastrointestinal (GI) surgery recovery following surgeries that include partial bowel resection with primary anastomosis. Source: FDA website
New Indications 10-21-13
Otrexup
The Food and Drug Administration (FDA) approved OtrexupTM (methotrexate subcutaneous auto-injector) for adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first-line therapy. Otrexup was also approved for adults with severe recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy. Source: FDA website
New Drug 10-14-13
GONAL-f RFF Redi-ject Pen
The Food and Drug Administration (FDA) approved Gonal-f® RFF Redi-ject Pen (recombinant follitropin alfa injection) for the development of multiple follicles in ovulatory individuals undergoing Assisted Reproductive Technology (ART) and for the induction of ovulation in individuals with functional anovulatory infertility without primary ovarian failure. The device is a disposable prefilled injector pen. Source: FDA website
New Drug 10-18-13
Ecoza
The Food and Drug Administration (FDA) approved EcozaTM (econazole nitrate topical foam) for the treatment of interdigital tinea pedis in individuals 12 years of age and older. Source: FDA website
New Drug 10-24-13
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have used > one disease-modifying antirheumatic drug (DMARD) that did not provide adequate relief. Source: FDA website
New Drug 10-22-13
Zohydro ER
The Food and Drug Administration (FDA) approved Zohydro ERTM (hydrocodone bitartrate extended-release capsules) for the management of severe pain. Source: FDA website
New Drug 10-25-13
Zorvolex
The Food and Drug Administration (FDA) approved ZorvolexTM (diclofenac capsules) for the treatment of mild-to-moderate acute pain in adults. Source: FDA website
New Drug 10-21-13
NovoLog FlexTouch
The Food and Drug Administration (FDA) approved NovoLog® FlexTouch® (insulin aspart prefilled delivery system) to improve glycemic control in diabetes mellitus. Source: FDA website
New Drug 11-01-13
Levemir FlexTouch
The Food and Drug Administration (FDA) approved Levemir® FlexTouch® (insulin detemir prefilled delivery system) to improve glycemic control in diabetes mellitus. Source: FDA website
New Drug 11-01-13
Opsumit
The Food and Drug Administration (FDA) approved Opsumit® (macitentan tablets) for the treatment of pulmonary arterial hypertension. Source: FDA website
New Drug 10-18-13
Gazyva
The Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab injection) for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia (CLL). Source: FDA website
New Drug 11-01-13
Aptiom
The Food and Drug Administration (FDA) approved Aptiom® (eslicarbazepine acetate tablets) for the treatment of partial-onset seizures. Source: FDA website
New Drug 11-11-13
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) for the treatment of mantle cell lymphoma (MCL) after at least one prior therapy. Source: FDA website
New Drug 11-13-13
Luzu
The Food and Drug Administration (FDA) approved Luzu® (luliconazole topical cream) for the treatment of skin fungal infections. Source: FDA website
New Drug 11-15-13
Cefepime
B. Braun Medical announced a voluntary recall of one lot of 1 g Cefepime for Injection and Dextrose Injection due to the presence of visible particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371031.htm Source: FDA website
Drug Recall 10-15-13
Specialty Medicine Compounding Pharmacy
Specialty Medicine Compounding Pharmacy announced a voluntary recall of all lots of certain unexpired sterile products due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371563.htm Source: FDA website
Drug Recall 10-21-13
Perrigo acetaminophen infant suspension
The Perrigo Company announced a voluntary recall of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 ml due to the potential that a small number of packages might contain an oral dosing syringe without dose markings. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373404.htm Source: FDA website
Drug Recall 11-02-13
Nexavar
The Food and Drug Administration (FDA) approved Nexavar® (sorafenib tablet) for the treatment of refractory thyroid cancer. Source: FDA website
New Indications 11-22-13
Varithena
The Food and Drug Administration (FDA) approved VarithenaTM (polidocanol injectable foam) for the treatment of varicose veins. Source: FDA website
New Drug 11-26-13
Noxafil
The Food and Drug Administration (FDA) approved Noxafil® (posaconazole delayed-release tablet) for the prevention of invasive Aspergillus and Candida infections in individuals 13 years and older. Source: FDA website
New Drug 11-26-13
Velphoro
The Food and Drug Administration (FDA) approved Velphoro® (sucroferric oxyhydroxide chewable tablet) for the treatment of hyperphosphatemia in individuals with chronic kidney disease (CKD) on dialysis. Source: FDA website
New Drug 11-28-13
Olysio
The Food and Drug Administration (FDA) approved OlysioTM (simeprevir capsule) for the treatment of chronic hepatitis C infection (genotype 1) as a component of a combination antiviral regimen. Source: FDA website
New Drug 11-22-13
Onfi
The Food and Drug Administration (FDA) announced that the anticonvulsant drug Onfi® (clobazam tablet and oral suspension) can cause rare but serious skin reactions. Changes to the drug label and Medication Guide have been approved. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm377340.htm Source: FDA website
Drug Warning 11-03-13
Rosiglitazone- containing medications
The Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs do not show an increased risk of heart attack compared to metformin and sulfonylurea for the treatment of type 2 diabetes. The FDA is requiring removal of the prescribing and dispensing restrictions for these drugs that were put into place in 2010. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376683.htm Source: FDA website
Drug Warning 11-25-13
FreeStyle and FreeStyle Lite
Abbott announced a voluntary recall of 20 lots of FreeStyle® and FreeStyle® Lite Blood Glucose Test Strips. These lots may produce erroneously low blood glucose results when used with the FreeStyle® Blood Glucose Meter and the FreeStyle® Flash Blood Glucose Meter (not in production since 2010) and the OmniPod® Insulin Management System. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376984.htm Source: FDA website
Drug Warning 11-28-13
Xiaflex
The Food and Drug Administration (FDA) approved Xiaflex® (collagenase clostridium histolyticum injection) for the treatment of Peyronie's disease. Source: FDA website
New Indications 12-06-13
Kcentra
The Food and Drug Administration (FDA) approved Kcentra® (prothrombin complex concentrate injection) for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adults needing urgent surgery or other invasive procedure. Source: FDA website
New Indications 12-16-13
Complera
The Food and Drug Administration (FDA) approved Complera® (emtricitabine/rilpivirine/tenofovir tablets) as a single tablet human immunodeficiency virus (HIV)-1 regimen for use in certain virologically suppressed adults on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Source: FDA website
New Indications 12-16-13
Feiba
The Food and Drug Administration (FDA) approved Feiba® (anti-inhibitor coagulant complex injection) for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors. Source: FDA website
New Indications 12-19-13
Mekinist and Tafinlar
The Food and Drug Administration approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) for combination use in unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Source: FDA website
New Indications 01-09-14
Sovaldi
The Food and Drug Administration (FDA) approved Sovaldi® (sofosbuvir tablets) for the treatment of chronic hepatitis C. Source: FDA website
New Drug 12-06-13
Tretten
The Food and Drug Administration (FDA) approved Tretten® (recombinant coagulation factor XIII A-subunit injection) for use in the routine prevention of bleeding in adults and children who have congenital Factor XIII A- subunit deficiency. Source: FDA website
New Drug 12-23-13
Orenitram
The Food and Drug Administration (FDA) approved OrenitramTM (treprostinil extended-release tablets) for the treatment of pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Group I patients to improve exercise capacity. Source: FDA website
New Drug 12-23-13
Isentress
The Food and Drug Administration (FDA) approved Isentress® (raltegravir oral suspension) for the treatment of human immunodeficiency virus (HIV)-1 infection in pediatric patients. Source: FDA website
New Drug 01-08-14
Anoro Ellipta
The Food and Drug Administration (FDA) approved AnoroTM EllipaTM (umeclidinium/vilanterol oral inhalation) for the treatment of chronic obstructive pulmonary disease (COPD). Source: FDA website
New Drug 12-18-13
Farxiga
The Food and Drug Administration (FDA) approved FarxigaTM (dapagliflozin tablets) to improve glycemic control, with diet and exercise, in adults with type 2 diabetes. Source: FDA website
New Drug 01-08-14
TRUEtrack and TRUEbalance blood glucose meters
Nipro Diagnostics announced a voluntary recall of a limited number of TRUEbalance® and TRUEtrack® blood glucose meters due an incorrect factory-set unit of measure. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380758.htm Source: FDA website
Drug Warnings 01-08-14
Abrams Royal Pharmacy sterile products
Abrams Royal Pharmacy announced a voluntary recall of all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/safety/recalls/ucm379313.htm Source: FDA website
Drug Warnings 12-19-13
Sodium Phosphate over-the-counter products
The Food and Drug Administration (FDA) is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and possible death. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380833.htm Source: FDA website
Drug Warnings 01-08-14
Pennsaid
The Food and Drug Administration (FDA) approved Pennsaid® (diclofenac sodium 2% topical solution) for the treatment of osteoarthritis pain of the knee. Source: FDA website
New Drug 01-17-14
Copaxone
The Food and Drug Administration (FDA) approved Copaxone® (glatiramer acetate 40 mg injection) for the treatment of multiple sclerosis. This new formulation can be administered three times a week. Source: FDA website
New Drug 01-28-14
Hetlioz
The Food and Drug Administration (FDA) approved HetliozTM (tasimelteon capsules) for the treatment of non-24-hour sleep-wake disorder (non-24) in blind individuals. Source: FDA website
New Drug 01-31-14
t:slim Insulin Cartridges
Tandem Diabetes Care announced a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump due to a risk for leaking. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381606.htm Source: FDA website
Drug Recall 01-14-14
Acetaminophen Prescription Combination Drug Products
The Food and Drug Administration (FDA) recommended that health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per dosage unit due to the potential for liver injury. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm381650.htm Source: FDA website
Drug Warning 01-14-14
Calcium gluconate
The Food and Drug Administration (FDA) notified healthcare professionals to follow up with individuals who received calcium gluconate 10% injections made by Rx Formulations in Mesa, AZ between November 7, 2013 and December 11, 2013. FDA testing confirmed the presence of microbial contamination in one lot of calcium gluconate product. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm Source: FDA website
Drug Warning 02-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) as a single agent for individuals with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Source: FDA website
New Indications 02-12-14
Kalydeco
The Food and Drug Administration (FDA) approved KalydecoTM (ivacaftor tablets) for use in individuals with cystic fibrosis (CF) ages 6 years older who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indications 02-21-14
Vimizim
The Food and Drug Administration (FDA) approved VimizimTM (elosulfase alfa injection) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Source: FDA website
New Drug 02-14-14
Northera
The Food and Drug Administration (FDA) approved NortheraTM (droxidopa capsules) for the treatment of symptomatic neurogenic orthostatic hypotension. Source: FDA website
New Drug 02-18-14
Tivorbex
The Food and Drug Administration (FDA) approved TivorbexTM (indomethacin capsules) for the treatment of mild-to-moderate acute pain in adults. Source: FDA website
New Drug 02-24-14
Myalept
The Food and Drug Administration (FDA) approved MyaleptTM (metreleptin injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in individuals with congenital generalized or acquired generalized lipodystrophy. Source: FDA website
New Drug 02-24-14
Bydureon Pen
The Food and Drug Administration (FDA) approved Bydureon® Pen (exenatide extended-release for injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug 03-03-14
Aveed
The Food and Drug Administration (FDA) approved AveedTM (testosterone undecanoate injection) as a testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism in adult males. Source: FDA website
New Drug 03-06-14
Xartemis XR
The Food and Drug Administration (FDA) approved XartemisTM XR (oxycodone/acetaminophen extended-release tablets) for the management of acute pain severe enough to require opioid treatment and in individuals for whom alternative options are ineffective, not tolerated or would otherwise be inadequate. Source: FDA website
New Drug 03-12-14
Qudexy XR
The Food and Drug Administration (FDA) approved QudexyTM XR (topiramate extended-release capsules) as initial monotherapy in individuals greater than 10 years of age with partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR is also approved as adjunct therapy in individuals greater than 2 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Source: FDA website
New Drug 03-12-14
Effexor XR 150 mg and Venlafaxine XR 150 mg
Pfizer announced a recall on one lot of 30-count Effexor XR® 150 mg extended-release capsules, one lot of 90-count Effexor XR 150 mg extended-release capsules, and one lot of 90-count Greenstone branded Venlafaxine 150 mg extended-release capsules. The recall is due to a report that one bottle of Effexor XR contained one capsule of Tikosyn® (dofetilide). Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm Source: FDA website
Drug Recall 03-07-14
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in individuals who have undergone hip or knee replacement surgery. Source: FDA website
New Indications 03-14-14
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) for the treatment of chronic idiopathic urticaria (CIU) in individuals greater than 12 years of age who remain asymptomatic despite H1-antihistamine therapy. Source: FDA website
New Indications 03-21-14
Impavido
The Food and Drug Administration (FDA) approved Impavido® (miltefosine capsules) in adults and adolescents for the treatment of visceral leishmaniasis, cutaneous leishmaniasis, and, mucosal leishmaniasis. Source: FDA website
New Drug 03-19-14
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of psoriatic arthritis. Source: FDA website
New Drug 03-21-14
Noxafil
The Food and Drug Administration (FDA) approved Noxafil® (posaconazole injection) for prophylaxis against invasive Aspergillus and Candida infections, in individuals at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft vs. host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia due to chemotherapy. Source: FDA website
New Drug03-14-14
Hemangeol
The Food and Drug Administration (FDA) approved HemangeolTM (propranolol oral solution) for the treatment of proliferating infantile hemangioma requiring systemic therapy. Source: FDA website
New Drug 03-17-14
Metronidazole Vaginal Gel 1.3%
The Food and Drug Administration (FDA) approved Metronidazole Vaginal Gel 1.3% for the treatment of bacterial vaginosis. Source: FDA website
New Drug03-26-14
Adacel
The Food and Drug Administration (FDA) approved Adacel® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; adsorbed injection) to immunize against tetanus, diphtheria, and pertussis in children as young as 10 years old. Source: FDA website
New Indications04-01-14
Alli
GlaxoSmithKline and Consumer Healthcare announced a recall of all AlliTM (orlistat capsules) weight loss products due to the possibility of product tampering. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391013.htm Source: FDA website
Drug Recall03-28-14
Alprolix
The Food and Drug Administration (FDA) approved AlprolixTM (coagulation Factor IX recombinant, Fc fusion protein injection) to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia B. Source: FDA website
New Drug03-28-14
Evzio
The Food and Drug Administration (FDA) approved EvzioTM (naloxone injection) for the emergency treatment of opioid overdose. Source: FDA website
New Drug04-03-14
Kalbitor
The Food and Drug Administration (FDA) approved Kalbitor® (ecallantide injection) for the treatment of acute attacks of hereditary angioedema (HAE) in individuals greater than 12 years old. Source: FDA website
New Indications04-03-14
Oralair
The Food and Drug Administration (FDA) approved Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract sublingual tablet) for the treatment of allergic rhinitis with or without conjunctivitis caused by certain grass pollens in individuals aged 10 to 65 years. Source: FDA website
New Drug04-02-14
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate capsules) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in individuals who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients. Source: FDA website
New Indications04-07-14
Topamax
The Food and Drug Administration (FDA) approved Topamax® (topiramate tablets) for prevention of migraines in adolescents aged 12-17 years old. Source: FDA website
New Indications03-28-14
Grastek
The Food and Drug Administration (FDA) approved Grastek® (Timothy grass pollen allergen extract sublingual tablet) for the treatment of grass-pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 5 to 65 years. Source: FDA website
New Drug04-15-14
Ragwitek
The Food and Drug Administration (FDA) approved RagwitekTM (short ragweed pollen allergen extract sublingual tablet) for the treatment of short ragweed pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 18 to 65 years. Source: FDA website
New Drug04-17-14
Tanzeum
The Food and Drug Administration (FDA) approved TanzeumTM (albiglutide subcutaneous injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug04-15-14
Cyramza
The Food and Drug Administration (FDA) approved CyramzaTM(ramucirumab injection) for the treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine- or platinum-containing chemotherapy. Source: FDA website
New Drug04-21-14
Sylvant
The Food and Drug Administration (FDA) approved SylvantTM (siltuximab injection) for the treatment of multicentric Castleman's disease (MCD). Source: FDA website
New Drug04-23-14
Arzerra
The Food and Drug Administration (FDA) approved Arzerra® (ofatumumab injection) for use in combination with chlorambucil for the treatment of previously untreated individuals with chronic lymphocytic leukemia (CLL) for whom, fludarabine-based therapy is considered inappropriate. Source: FDA website
New Indications04-17-14
Cubicin
Cubist Pharmaceuticals announced a recall of one lot of Cubicin® (daptomycin 500 mg injection) due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394025.htm Source: FDA website
Drug Warning04-18-14
Lidocaine
Hospira announced a recall of one lot of Lidocaine 1%, 10 mg/mL, 30 mL single dose, preservative-free vials due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394026.htm Source: FDA website
Drug Warning04-19-14
Purixan
The Food and Drug Administration (FDA) approved PurixanTM (mercaptopurine oral suspension) for the treatment of individuals with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Source: FDA website
New Drug04-29-14
Zykadia
The Food and Drug Administration (FDA) approved ZykadiaTM (ceritinib capsules) for individuals with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug04-29-14
Incruse Ellipta
The Food and Drug Administration (FDA) approved IncruseTM Ellipta® (umeclidinium oral inhaler) for the long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug04-30-14
Epanova
The Food and Drug Administration (FDA) approved EpanovaTM(omega-3-carboxylic acids capsules) as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (>500 mg/dL). Source: FDA website
New Drug05-06-14
Zontivity
The Food and Drug Administration (FDA) approved ZontivityTM (vorapaxar tablets) to reduce the risk of heart attack, stroke, cardiovascular death, and need for coronary revascularization in individuals with a previous heart attack or blockages in the arteries to the legs. Source: FDA website
New Drug05-08-14
Kogenate FS
The Food and Drug Administration (FDA) approved Kogenate FS® (antihemophilic factor VIII, recombinant injection) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Source: FDA website
New Indications05-12-14
GenStrip Blood Glucose Test Strips
The Food and Drug Administration (FDA) has advised consumers and health care professionals to stop using GenStrip Blood Glucose Test Strips by Shasta Technologies because the strips may report incorrect blood glucose levels. The FDA recommends the use of alternative glucose test strips designed for use with the LifeScan OneTouch family of glucose meters. Contact your health care professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm Source: FDA website
Drug Warning04-29-14
Entyvio
The Food and Drug Administration (FDA) approved Entyvio® (vedolizumab injection) for the treatment of adults with moderate to severe ulcerative colitis and Crohn's disease. Source: FDA website
New Drug05-19-14
Dalvance
The Food and Drug Administration (FDA) approved Dalvance™ (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). Source: FDA website
New Drug05-23-14
Natesto
The Food and Drug Administration (FDA) approved Natesto™ (testosterone nasal gel) for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Source: FDA website
New Drug05-29-14
Vectibix
The Food and Drug Administration (FDA) approved Vectibix® (panitumumab injection) for use in combination with FOLFOX chemotherapy as a first-line treatment in individuals with wild-type KRAS (exon 2) metastatic colorectal cancer. A companion diagnostic test was also approved. Source: FDA website
New Indications05-27-14
Aloxi
The Food and Drug Administration (FDA) approved Aloxi® (palonosetron injection) for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in children aged 1 month to < 17 years. Source: FDA website
New Indications05-28-14
Lunesta
The Food and Drug Administration (FDA) announced a warning that the insomnia drug Lunesta® (eszopiclone tablets) and its generics may cause next-day impairment of driving and other activities that require alertness. The agency recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397536.htm Source: FDA website
Drug Warning05-15-14
Pradaxa
The Food and Drug Administration (FDA) completed a study comparing Pradaxa® (dabigatran capsules) to warfarin and found that Pradaxa was associated with a lower risk for stroke and death but a higher risk for gastrointestinal bleeding compared with warfarin. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm Source: FDA website
Drug Warning05-13-14
Labetalol
Hospira announced a recall of one lot of Labetalol Hydrochloride Injection 100 mg/20 mL multidose vial due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397775.htm Source: FDA website
Drug Recall05-16-14
Vogelxo
The Food and Drug Administration (FDA) approved Vogelxo™ (testosterone topical gel) for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Source: FDA website
New Drug06-04-14
Jublia
The Food and Drug Administration (FDA) approved Jublia® (efinaconazole topical solution) for the treatment of onychomycosis of the toenails. Source: FDA website
New Drug06-09-14
Eloctate
The Food and Drug Administration (FDA) approved Eloctate™ (coagulation factor VIII recombinant, Fc fusion protein injection) for use in adults and children with hemophilia A. Source: FDA website
New Drug06-09-14
Bunavail
The Food and Drug Administration (FDA) approved Bunavail™ (buprenorphine/naloxone buccal film) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug06-09-14
Nascobal
The Food and Drug Administration (FDA) approved Nascobal® (cyanocobalamin nasal spray) single-use disposable device for the maintenance of normal hematologic status in pernicious anemia and for other vitamin B12 deficiencies. Source: FDA website
New Drug06-10-14
Azilect
The Food and Drug Administration (FDA) approved Azilect® (rasagiline tablets) for the expanded indication of adjunct treatment to dopamine agonists in Parkinson's disease. Source: FDA website
New Indication06-09-14
Advocate Redi-Code+
Diabetic Supply of Suncoast announced a voluntary recall of all Advocate Redi-Code+ blood glucose test strips manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the test strips are designed to be used with. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm Source: FDA website
Drug Recall06-11-14
Sivextro
The Food and Drug Administration (FDA) approved SivextroTM (tedizolid tablet and injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA). Source: FDA website
New Drug06-23-14
Afrezza
The Food and Drug Administration (FDA) approved Afrezza® (human insulin injection) for the improvement of glycemic control in adults with diabetes mellitus. Source: FDA website
New Drug06-30-14
Beleodaq
The Food and Drug Administration (FDA) approved BeleodaqTM (belinostat injection) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Source: FDA website
New Drug07-3-14
Ozurdex
The Food and Drug Administration (FDA) approved Ozurdex® (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in adults who have an artificial lens implant or who are scheduled for cataract surgery. Source: FDA website
New Indications07-1-14
Lidocaine Viscous
The Food and Drug Administration (FDA) announced that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. The agency is requiring a Boxed Warning to be added to labeling. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm Source: FDA website
Drug Warning06-26-14
Over-the-Counter Topical Acne Products
The Food and Drug Administration (FDA) announced that certain over-the-counter (OTC) topical acne products may cause rare but serious potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv®, Neutrogena®, MaxClarity™, Oxy™, Ambi®, Aveeno®, Clean & Clear®, and as store brands. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm Source: FDA website
Drug Warning06-25-14
Coumadin
Bristol-Myers Squibb announced a voluntary recall of six lots of Coumadin®, (warfarin injection) 5 mg single-use vials due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403583.htm Source: FDA website.
Drug Recall07-1-14