FDA to allow dispensing of GSK's Type 2 diabetes drug Avandia in retail pharmacies again

FDA relaxes restrictions on drug following release of new clinical trial data

SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

The Food and Drug Administration said Monday it would require removal of some restrictions on GlaxoSmithKline's Type 2 drug Avandia (rosiglitazone), which were placed following findings from a series of studies starting in 2007 of an increased risk in heart attacks in patients taking it. The agency's decision was based on results of a clinical trial showing no elevated risk of heart attack or deaths in patients taking Avandia compared with those taking standard-of-care diabetes drugs.

"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."

In May 2011, the FDA announced that as of November of that year, Avandia would no longer be available in retail pharmacies and would only be available through mail order. Once the latest changes are finalized, the FDA said Monday, it will be available in retail pharmacies again.


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