FDA panel backs changes to Avandia safety rules

WASHINGTONFederal health experts recommend modifying safety restrictions on former 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 (FDA) advisers voted to change measures that currently limit patient access to GlaxoSmithKline's Avandia. Under current rules, patients must sign a waiver that they understand the drug's risks before getting a prescription.

Thirteen members of the advisory panel voted for modification of the safety restrictions, while seven others voted to remove the restrictions entirely, Reuters reported. Five panel members favored keeping current safeguards in place without changes.

The panel's vote is a recommendation to the FDA and is not binding. Advisers will now discuss specific changes to the 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.

"I think it's really kind of too late," CBS medical correspondent Dr. Jon Lapook told CBS This Morning on Thursday about the drug's chances of returning to blockbuster status. "There are other medications that treat diabetes well. I think it's not going to come back as a big drug."

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