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  5. Drug Safety Oversight Board Meeting - March 19, 2015
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board Meeting - March 19, 2015

The following Drug Safety Communications (DSCs) have posted since the January 15, 2015 DSB meeting:

  • February 25, 2015:  Multi-dose Diabetes Pen DevicesFDA is requiring additional label warnings prohibiting sharing of these injectable medicines.  This is being done in an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only.  Insulin pens and pens for other injectable diabetes medicines should never be shared among patients, even if the needle is changed. Sharing pens can result in the spread of serious infections from one patient to another. To promote safe use, FDA is requiring that pens and packaging containing multiple doses of insulin and other injectable diabetes medicines display a warning label stating “For single patient use only.”  
  • March 3, 2015:  Testosterone ProductsFDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.  FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.  
  • March 9, 2015:  Chantix (varenicline)FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with Chantix have been reported.  FDA has approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.  

The Board heard three presentations:

  1. Jason Woo, MD, Immediate Office/Office of Generic Drugs (OGD)/CDER, presented an overview of generic drug regulation.
  2. Kathleen Uhl, MD, Director/OGD/CDER, presented an overview of the Generic Drug User Fee Amendment (GDUFA).
  3. John Peters, MD, Director/Office of Bioequivalence/OGD/CDER, presented an overview of the safety surveillance of generic drugs.

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.


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