Latebreakers: FDA holds action on Avandia

June 4, 2007

The FDA said it will wait to further evaluate data submitted by manufacturer GlaxoSmithKline regarding the safety of its diabetes drug rosiglitazone (Avandia).

The FDA said it will wait to further evaluate data submitted by manufacturer GlaxoSmithKline regarding the safety of its diabetes drug rosiglitazone (Avandia). The company provided results of a meta-analysis of 42 studies to the FDA, a study that also appeared in the on-line edition of New England Journal of Medicine on May 21, which showed a 64% increased risk of cardiovascular death in patients taking rosiglitazone and a 43% increased risk of heart attack. CDER's director of the Office of New Drugs, Robert Meyer, said the FDA would like to reevaluate the studies because it had some "issues" with the data and could not make a definitive decision. He also said other long-term studies show contradictory results regarding the cardiovascular risk. Once the data are reevaluated, an advisory committee will be convened to discuss the findings, Meyer said. Meanwhile, patient advocacy group Consumers Union criticized the way the FDA has handled the data, which the agency reportedly received in August 2006, and strongly supports legislation that will improve FDA's postmarketing surveillance system.