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Avandia Could Make Comeback After FDA Panel's Vote of Confidence

Jun 7, 2013

Avandia is a step closer to being free of restrictions that have kept it out of most diabetics’ medicine cabinets for the past few years.

This week, an advisory committee to the U.S. Food and Drug Administration (FDA) voted to recommend that restrictions placed on Avandia in 2010 be lifted, according to a report from Reuters. A vote of confidence like this from an FDA advisory committee does not necessarily mean the agency will act in step with the panel. Instead, the agency will take the panel’s recommendation into consideration for a future ruling.

At that time in 2010, data from a clinical study conducted by the maker of Avandia, GlaxoSmithKline, was considered flawed by the FDA, and the agency acted to remove the drug from the market almost entirely. Avandia had been linked in previous clinical trials and actual outcomes to a fatal heart risk.

When those restrictions were put in place, Avandia was the top-selling drug in the treatment of type 2 diabetes. As the FDA acted to restrict the drug – requiring a physician, pharmacist, and patient to sign off on it – several European markets were removing Avandia entirely. Today, according to Reuters data, about 3,000 people take Avandia in the U.S., compared with 120,000 at the time restrictions were put in place.

According to Reuters, half the 26 members of the FDA advisory panel voted to loosen the restrictions placed on Avandia in 2010; they said that the dangers posed by this particular type 2 diabetes drug were no different from the risks associated with similar medications. Just five panel members voted to keep the current restrictions in place.

The year before the restrictions on Avandia were put in place, GlaxoSmithKline, manufacturer of the drug, convened a clinical trial titled Record, which examined whether the drug was linked to fatal heart attacks among the diabetics taking it.

Heart disease is the leading cause of death for diabetics. When the study was released, GlaxoSmithKline announced that it found no link between its drug and heart attacks. The FDA and much of the medical community rejected that assertion, and the agency described as flawed the means by which GlaxoSmithKline collected its data for the study, according to our previous accounts. Disputing the study’s results, the FDA said it found at least a dozen patients included in the study who had developed a heart attack while taking the drug.

Armed with the panel’s recommendation, the FDA must now decide whether to go along with that decision or to stand behind its decision three years ago. It could also take the option of ordering new Avandia studies to determine its true safety profile, according to Reuters.

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