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Avandia Gets Equivocal Vote From FDA Panel

An advisory panel to the U.S. Food and Drug Administration (FDA) reached a mixed vote regarding the fate of the diabetes drug rosiglitazone (Avandia) on Wednesday.

Although 12 of the 33 panelists voted to withdraw rosiglitazone from the market entirely‚ the majority voted to keep it available‚ possibly with new, tougher restrictions. The intense debate over rosiglitazone was illustrated by the FDA panel votes, which came after reviewing more than 1‚000 pages of information and hearing from 18 speakers. FDA Commissioner Margaret A. Hamburg is expected to make the final decision about the drug. Seven members of the FDA panel voted that rosiglitazone should remain available‚ with additional warnings on the drug’s label‚ and 10 voted for label revisions and sale restrictions. Another three members voted for no change in the drug’s status‚ and one member abstained. The panel also concluded that there was sufficient evidence that rosiglitazone may increase the risk of heart attacks and strokes‚ but not enough evidence that it increased the overall risk of death. The committee also voted to recommend that the FDA continue to allow a large‚ international study by drugmaker GlaxoSmithKline that intends to compare the safety of rosiglitazone with pioglitazone (Actos), another popular diabetes drug.