Joint FDA advisory committee weighs in on fate of Avandia

PHILADELPHIA A joint advisory committee of the Food and Drug Administration has voted to recommend allowing a diabetes drug made by GlaxoSmithKline to remain on the market, though it still has to undergo the agency’s scrutiny.

Twenty of the combined 33 members of the FDA’s Endocrinologic and Metabolic Drugs advisory committee and Drug Safety and Risk Management advisory committee voted to recommend allowing Avandia (rosiglitazone) to remain on the market, though 17 of them recommended restricting its sales or enhancing its warning labels, while three voted to allow it to remain on the market with no labeling changes; another 12 recommended withdrawing it from the market, and one member abstained.

The drug had become controversial after a 2007 clinical study found that it increased the risk of heart attacks. Nevertheless, an earlier FDA advisory committee recommended that it remain on the market at the time.

Final authority on the fate of Avandia rests with the FDA, which is not bound by advisory committees’ votes but will take them into account when making a final decision.

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