Mixed vote on rosiglitazone

Mixed vote on rosiglitazone

The same FDA committee also recently ruled on the embattled diabetes drug rosiglitazone (Avandia^®), and the vote was decidedly mixed. GlaxoSmithKline's rosiglitazone has been under intense scrutiny since 2007 when a study from the Cleveland Clinic linked the drug to an increased rate of heart attacks (N Engl J Med 2007;356:2457-2471). Recently, the FDA has evaluated reports from the New York Times and others that the company suppressed crucial safety information about the drug for years. At the July meeting of the Endocrinologic and Metabolic Advisory Committee, 12 members voted to withdraw rosiglitazone from the market, 10 voted to keep the drug on the market with additional warnings and restrictions, 7 wanted additional warnings only, and 3 members voted for no label changes. The FDA is not required to follow the advice of its advisory panels, and it is unclear what course they will take when they finally make a decision later this year.