May 23, 2007Avandia may become a repeat of Vioxx debacle
Research conducted on the diabetes drug Avandia by Dr. Steven Nissen and recently published in the New England Journal of Medicine has gotten a lot of attention. Avandia, made and sold by GlaxoSmithKline, is drawing parallels with Vioxx, the arthritis medication withdrawn in September 2004 because of heart safety concerns. Some legal observers now think it may become another one-time blockbuster drug with more risks than benefits.Similar questions about drug regulation have arisen with Vioxx and Avandia. In both cases, officials at the Food and Drug Administration apparently knew about their problems long before taking action.
Dr. Harlan Krumholz of Yale University and Dr. Stuart Seides of Washington Hospital Center have openly wondered why the agency waited so long before acting to protect consumers. One FDA spokesperson, Robert Meyer, insists the agency is still reviewing the data posted last year on GSK’s website.
Two things the agency might do are to slap a “black-box” warning on Avandia’s label or pull it from the market entirely. In fact, it added a new warning last year about a heightened risk of heart attacks. The data came from a trial among patients who already had congestive heart failure.