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FDA Panel Votes to Change Tight Restrictions on Diabetes Drug Avandia
Date:6/7/2013

By Dennis Thompson
HealthDay Reporter

THURSDAY, June 6 (HealthDay News) -- An expert advisory panel to the U.S. Food and Drug Administration voted narrowly Thursday to recommend changing tough safety restrictions on the diabetes drug Avandia, which was all but banned nearly two years ago because of reported links to heart problems.

The panel's decision came after a review of data that suggested the medication might not be as harmful as once thought.

However, because of initial concerns over cardiovascular safety, Avandia had been taken off drugstore shelves and its use restricted to patients who first signed a waiver saying they understood the possible risks. The drug was also dispensed only through specially registered pharmacies.

But the new recommendation might change all that. Thirteen members of the 26-person panel voted to alter the safety restrictions, the Associated Press reported, while seven voted to remove the restrictions altogether. Five panelists voted to keep the restrictions in place, while one panelist voted to withdraw Avandia from the marketplace.

The exact nature of any changes to current restrictions are yet to be decided. The FDA is not obligated to follow its advisory panels' decisions, but it usually does.

The panelists spent the past two days reconsidering evidence from an independent review by Duke University researchers of Avandia's original clinical trial, called RECORD. That review did uncover some previously unreported cases of heart complications and deaths, but the Duke team concluded that those cases did not significantly raise the overall risk of heart disease.

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

The drug's maker, GlaxoSmithKlin
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FDA Panel Votes to Change Tight Restrictions on Diabetes Drug Avandia
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