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acute pancreatitis while taking these medicines, but the agency has recently received new information about an unpublished study that found pancreatic cells taken from patients taking an incretin mimetic had developed precancerous cellular changes called pancreatic duct metaplasia.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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