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PHILADELPHIA — An advisory committee to the Food and Drug Administration has recommended that GlaxoSmithKline PLC’s (GSK) diabetes drug Avandia should remain on the market, but possibly with tough new restrictions and new warnings.
Of the advisory panel’s 33 members, 12 voted for withdrawal of Avandia, 10 favored restricting its sales and enhancing its label warnings, seven voted only for enhanced warnings, and three voted for continued sales with present warnings unchanged.
Dr. Janet Woodcock, director of the drug center at the FDA, said that the agency viewed the panel’s recommendations with seriousness and that it would consider its options. The agency often acts on the suggestions of its advisory groups, but the split vote in this case made the FDA’s next move on Avandia difficult to gauge.
Approved in 1999, Avandia helps control blood glucose levels in people with diabetes by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was pulled from the market because it caused liver damage. The other drug in the class, Actos, made by Takeda, has been deemed safe.
Dr. Ellen Strahlman, GSK’s chief medical officer, said the company would work with the FDA "in the best interest of diabetes patients who face this chronic and serious disease." She added, "Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."
Avandia, at one time the No. 1 selling diabetes medicine worldwide, saw its volume plummet in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, linked it to increased risk of heart attacks. An advisory panel that year confirmed the increased risk but voted to keep Avandia on the market.
Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday for withdrawal or sales limitations. Those limits could mean that patients would have to seek special permission to get the drug.
