Safety Alerts & Recalls

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FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges
The Food and Drug Administration (FDA) has reviewed the safety data on nicotine replacement therapy (NRT) products that are used to help people stop smoking and has decided to delete some of the warnings and limitations that are currently included in the label. Nicotine gum, transdermal nicotine patch, and nicotine lozenge products are the three types of NRT that are approved by FDA for over-the-counter (OTC) purchase by adult consumers ages 18 and above. These products help people quit smoking by supplying controlled amounts of nicotine to ease withdrawal symptoms. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm?source=govdelivery
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FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs
The Food and Drug Administration (FDA) has announced that it will investigate whether drugs in the new class of medicine for Type 2 diabetes called incretin mimetics may increase patients' risk of developing precancerous changes in the pancreas, as well as of developing acute pancreatitis. Incretin mimetics are often called "gliptins" and include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). The FDA already has issued consumer warnings about the potential risk of developing acute pancreatitis while taking these medicines, but the agency has recently received new information about an unpublished study that found pancreatic cells taken from patients taking an incretin mimetic had developed precancerous cellular changes called pancreatic duct metaplasia. The FDA has asked the researchers to share their methods and findings with the agency so that they can investigate this risk in more detail. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm?source=govdelivery
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Date Published Title Drug Source
2013-04-01 FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges Nicotine FDA
2013-03-15 FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs Sitagliptin FDA
2013-03-12 FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax) Azithromycin FDA
2013-02-25 Affymax and Takeda Announce a Recall of All Lots of Omontys (Peginesatide) Injection Peginesatide Manufacturer
2013-02-03 Novartis Recalls Several Lots of Triaminic® and Theraflu Warming Relief® Syrups Manufacturer
2013-01-18 Rugby Natural Iron Supplement Recalled Because Bottle May Contain Nausea Medicine Meclizine Iron FDA
2013-01-14 Abbott Laboratories Recalls Single Lot of Synthroid tablets, 150 mcg Levothyroxine FDA
2013-01-14 Mylan Pharmaceuticals Inc. Recalls Several Lots of Tacrolimus Capsules 0.5 mg Tacrolimus FDA
2013-01-10 FDA Lowers Recommended Dose of Sedative Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) Zolpidem FDA
2013-01-03 Physicians Total Care Recalls Several Lots of Enjuvia Tablets Estrogens Conjugated FDA
2013-01-02 Watson Pharma Recalls Select Lots of Caziant (Desogestrel and Ethinyl Estradiol) Tablets Desogestrel with Ethinylestradiol FDA
2013-01-02 Genentech USA, Inc. Recalls Several Lots of CellCept Capsules, 250 mg Mycophenolate FDA
2013-01-02 Johnson and Johnson Recalls Several Lots of Clean & Clear Advantage, 3-in-1 foaming Wash Salicylic Acid FDA
2012-12-20 Pradaxa Contraindicated in Patients With Mechanical Heart Valves Dabigatran FDA
2012-12-19 FDA Warns That Hepatitis C Drug Incivek Can Cause Potentially Fatal Skin Reactions Telaprevir FDA
2012-12-19 Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination Manufacturer
2012-12-17 FDA Warns Against Use of Xyrem With Alcohol, Insomnia Medicines, and Others Sodium Oxybate FDA
2012-12-12 FDA Publishes Results of Safety Review Update of Chantix and Risk of Heart Attack and Stroke Varenicline FDA
2012-12-11 Proctor and Gamble Recalls Select Lots of Vicks NyQuil Cold & Flu, Nighttime Relief FDA
2012-12-11 GlaxoSmithKline Recalls Several Lots of Advair HFA 45/21 Inhalers Fluticasone Propionate with Salmeterol FDA