The FDA’s advisory committee on endocrinologic and metabolic drugs today began evaluating the most recent studies on the safety of GlaxoSmithKline’s diabetes drug Avandia, which some politicians and scientists have accused of increasing the risk of cardiovascular complications. Ultimately, the committee will call for stricter warning labels on Avandia, restriction of its prescription to certain specialists, or its withdrawal from the market. While the FDA is not required to implement the recommendations made by such advisory panels, the agency has historically acted on their evaluations more often than not.
ACSH’s Dr. Gilbert Ross, who has followed this issue over the past decade, believes that GlaxoSmithKline may wind up pulling the drug from the market because of mounting litigation risks. “It seems that Avandia has been shown by observational studies — mostly retrospective studies, which cannot prove cause and effect — to have more adverse effects than Actos, a similar diabetes drug currently on the market,” says Dr. Ross. “Whether or not you believe that Actos is safer than Avandia, why do we suddenly have this new hurdle to overcome for a drug to stay on the market — that a new drug not only has to be safe and effective, but safer and more effective than a competitor’s drug?”