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Tuesday, July 31, 2007

FDA Panel Weighs in on Avandia

Yesterday, Dr. David Graham of the FDA recommended to a panel of scientific advisors the diabetes drug Avandia be pulled from the market. Studies have shown the drug may lead to an increased risk of heart attacks.

In a 20-3 vote, the panel agreed the drug increases the risk of heart attacks, according to The New York Times.

But the panel did not concur with Graham's assessment. The panel voted 22 to 1 to leave the drug on the market. Instead, the panel recommended the drug's packaging include warnings of the potential side effects. FDA will make the final decision on the drug's fate and may or may not choose to adopt the panel's recommendations.

On a related note, NPR reported a good story this morning on post-market drug safety. Dr. Bruce Psaty of the University of Washington describes how FDA and drug makers monitor the safety of drugs after they are approved for consumer use and why these processes are often insufficient. Listen to it here.