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FDA panel wants changes to Avandia safety measures

FDA panel wants changes to Avandia safety measures

June 6th, 2013 in News

WASHINGTON (AP) - Federal health experts have recommended changing safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously believed.

A majority of Food and Drug Administration advisers voted to modify or remove measures that currently limit patient access to GlaxoSmithKline's Avandia. Among other rules, patients currently must sign a waiver that they understand the drug's risks before getting a prescription. The drug can only be dispensed by specially registered pharmacies.

Of the panel's 26 experts, 13 voted to modify the safety restrictions while seven voted to remove them entirely. Five panelists voted to keep the measures in place without changes, while one panelist voted to withdraw Avandia completely.

The panel's vote is a recommendation to the FDA and is not binding. Panelists are now discussing specific modifications to the safety restrictions.

Avandia was once the best-selling diabetes drug in the world, but sales plummeted after heart attack concerns emerged in 2007. In 2010 the FDA limited access to the drug and European regulators banned the pill.

The FDA convened this week's two-day panel meeting to consider a new analysis of Avandia's cardiovascular safety performed by Duke University experts.

Those researchers reexamined the lone GlaxoSmithKline study designed to measure Avandia's heart risks, which has been subject to scrutiny since its release in 2009. Panelists expressed confidence in the reanalysis, which concluded that Avandia does not increase the risk of heart attack more than older diabetes medicines.

"I'm considerably reassured, in light of the reanalysis, that the magnitude of risk we're talking about here is not very great," said Dr. Dale Hammerschmidt of the University of Minnesota, who voted to modify the safety limits.