Drug Safety and Surveillance: the Case of Avandia

Drug Safety and Surveillance: the Case of Avandia

David J. Margolis and Brian L. Strom

A year ago, a meta-analysis published in The New England Journal of Medicine sounded alarms about the cardiovascular safety of the popular diabetes drug Avandia (rosiglitazone). The study caused both policymakers and the public to question the Food and Drug Administration’s ability to ensure the safety of drugs brought to the marketplace, and evoked memories of Vioxx, the painkiller withdrawn from the market in 2004 because of its link to heart attacks. A year after the Avandia story broke, this Clinical Brief revisits the controversy, summarizes a new study of the cardiovascular safety of diabetes drugs, and analyzes the policy implications for the drug approval process.