The Verdict: Avandia® Stays on the Market

Filed in archive News , Treatment on July 31, 2007

As voted by the FDA panel of advisers, GlaxoSmithKline's controversial diabetes drug Avandia® should stay on the market despite the drug being linked to increased risk of heart attack.

Advisers voted 22-1 in favor of keeping Avandia on the U.S. market, while acknowledging the risks of the drug. This is not a binding vote, but is taken as a suggestion to FDA regulators.

Nonetheless, the panel - meeting in Gaithersburg, Md. - also voted 20-3 that data shows that Avandia increases the risk of cardiac ischemia, a condition that blocks blood flow and oxygen to certain parts of the body, in patients with the most common type of diabetes.

Earlier Monday, an adviser suggested that Avandia be taken off the market because it increases cardiovascular risk, but GlaxoSmithKline (down $0.20 to $49.43, Charts), the maker of the drug, disputed the comments.

Are you surprised (or not) with this decision?

Read the full report.