In a split vote, the majority of a 33-member Food and Drug Administration advisory panel has recommended keeping the controversial diabetes drug Avandia on the market.
FDA panel lets Avandia stay on market
The decision comes on heels of an earlier vote today in which the majority of panel members said Avandia, made by GlaxoSmithKline, is more likely than its competitors to cause heart attacks in patients using the drug. Despite that determination, the panel in a split vote based on five different possible scenarios voted 20 to 12 to recommend keeping Avandia on the market, according to results supplied by an FDA spokeswoman. One panel member abstained from voting. The agency will use the recommendation to guide its final decision on the fate of Avandia.
The vote went as follows: no members voted to allow the drug to remain on the market and also to remove the current label warnings of increased cardiovascular risks; three members voted to continue sales of Avandia with no label changes; seven voted to allow continued sales of the drug, but also to add additional label warnings; 10 voted to allow continued sales of the drug, but also to require additional label warnings and restrictions on who can prescribe the drug; and 12 panel members voted to remove the drug from the market.
“Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease,” Dr. Ellen Strahlman, GSK's chief medical officer, said. “Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine.”
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