FDA Should Ease Restrictions on Avandia, Panel Says
By THOMAS M. BURTON
SILVER SPRING, Md.—A Food and Drug Administration advisory committee recommended, on a divided vote, that the agency ease restrictions on sale of the onetime blockbuster diabetes drug Avandia.
If the FDA follows this advice, it would mean a remarkable about-face for the agency, which issued sharp restrictions on Avandia in 2010 over cardiac concerns. The panel's majority said it no longer thinks the heart worries are as proven and serious as once believed.
Thirteen of 26 panelists voted to ease restrictions, and seven more wanted the curbs removed entirely. But—reflecting the complex nature of the evidence —five members wanted restrictions unchanged, and one panelist wanted the drug pulled from the U.S. market.
"There remains considerable uncertainty, but I do favor loosening the restrictions," said National Institutes of Health statistician and panel member Erica H. Brittain.
