FDA Advisory Committees Recommend Keeping Avandia on Market

Two FDA advisory committees voted July 30 to recommend keeping GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia on the market, although the committee also agreed that the drug appears to increase the risk of adverse cardiovascular events.

The committees voted 22-1, with no abstentions, to keep Avandia (rosiglitazone maleate) on the market. The members did not make any recommendations about what else the FDA should do, although most suggested adding warnings to the product’s labeling. Last month, the FDA requested a black box warning for Avandia and diabetes drug Actos (pioglitazone HCl), citing the increased risk of congestive heart failure.

The committees also voted 20-3 to agree that the drug increased the risk of cardiac ischemic events. However, members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee disagreed about the quality of all the Avandia studies, including meta-analyses, observational studies and large, randomized controlled studies. 

Some of the members called for more long-term studies and studies that focused on specific patient groups, such as those taking insulin and older diabetic patients.

The advisory committees held the joint meeting to discuss diabetes drug class thiazolidinediones, with a focus on Avandia. The agency convened the meeting after a meta-analysis appeared in the New England Journal of Medicine (NEJM) in May showing that Avandia increased the risk of death from cardiovascular causes by 64 percent.

Sales of Avandia fell 22 percent in the second quarter to $715 million after the NEJM meta-analysis was published, according to GSK.