FDA Leaves Avandia on Market, with Restrictions

Posted September 25, 2010 in Products Liability by Arthur Buono

Doctors can continue to prescribe the diabetes drug Avandia, the FDA announced on Thursday. The decision restricted the drug to persons with Type II diabetes who don’t respond to any other treatment. Avandia has been linked to heart and circulation problems, including heart attacks and strokes.

     
  • Once popular diabetes drug’s use severely restricted
  • Action comes in response to post-approval safety studies
  • FDA’s missions of safety and innovation create regulatory tension

 

Diabetes Drug Linked to Heart Attacks, Strokes

Avandia has been under fire since 2007. That’s when scientific data first linked the drug to heart trouble. Doctors prescribed Avandia to one million Americans in 2006. The drug’s been marketed since 1999. The evidence of serious side-effects prompted lots of Avandia-related lawsuits.

Thursday’s announcement stems from FDA’s postmarket drug safety responsibilities. The Food and Drug Administration Amendments Act of 2007 (FDAAA) empowered the FDA to track drug safety after approval. The FDAAA also required FDA to communicate better with patients and providers about post-approval drug safety information. Conflicts within FDA between the office that approves new drugs and the office that oversees drug safety prompted the legislation.

The FDA’s mission includes ensuring the drugs we take are safe and effective. It’s also charged with speeding drug innovations. These two goals can collide in some cases, creating conflict within the FDA. That’s what prompted the FDAAA amendments. Of course, the FDA’s other mission is the safety and wholesomeness of the nation’s food supply. FDA most recently made news in this area with the massive salmonella-related egg recall.

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