GlaxoSmithKline Issues Statement in Response to FDA Advisory Committee Vote on Avandia

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GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12).
The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered by the FDA in making its final decision.  Pending the FDA’s decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.

GSK’s Chief Medical Officer, said that 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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