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FDA softens stance on Avandia

June 10, 2013
by Pamela Tabar, Editor-in-Chief
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A Food and Drug Administration (FDA) panel voted to ease the restrictions placed on the Type 2 diabetes drug Avandia (rosiglitazone), deciding that the drug is no more or less dangerous than other diabetes medications.

On Thursday, 20 of the 26 FDA drug safety panel members voted to lessen or remove the strict labeling of the drug. Five members wanted the drug to remain restricted, and one member voted to remove Avandia from the market, noted a press release from the drug's manufacturer, GlaxoSmithKline (GSK).

Avandia has been under FDA restrictions for the past three years, shadowed by claims that the drug increased the risk of heart attacks and that GSK had not been forthright about publicizing the risks. But a new review conducted by the Duke Clinical Research Institute arrived at similar data as the original outcomes trial conducted by GSK, tallying a victory for the pharmaceutical giant.

The upturn in fortune may be too late for Avandia, many say. GSK reports that less than 3,500 people currently take the medication, which had once earned the company $3 billion in sales.

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