Regulatory Action on Rosiglitazone

Regulatory Action on Rosiglitazone by the U.S. FDA

NEJM | September 23, 2010 | Topics: Drugs, Devices, and the FDA

Janet Woodcock, M.D., Joshua M. Sharfstein, M.D., and Margaret Hamburg, M.D.

There have been ongoing concerns about the safety of the diabetes drugs containing rosiglitazone (Avandia, Avandaryl, and Avandamet) — a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In 2007, a meta-analysis of controlled clinical trials found increases in the risk of myocardial infarction and a near-significant increased risk of death from cardiovascular causes when rosiglitazone was compared with placebo or with standard diabetes drugs.¹ Following an advisory committee meeting held in July 2007, the U.S. Food and Drug Administration (FDA) added information about the possibility of ischemic cardiovascular risk to the drug’s existing boxed warning. At the same time, the FDA also required the sponsors to conduct a head-to-head cardiovascular safety trial of rosiglitazone versus pioglitazone — the other antidiabetic drug in this class available in the United States. After new data became available, the FDA held a second advisory committee meeting on rosiglitazone safety on July 13 and 14, 2010. On September 23, 2010, the FDA announced regulatory actions stemming from these deliberations

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The case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term. The FDA is committed to advancing the science of drug safety evaluation, during both drug development and in the postmarketing period.

Editor’s note: The European Medicines Agency also took regulatory action on rosiglitazone on September 23 (www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500096996.pdf).

This article (10.1056/NEJMp1010788) was published on September 23, 2010, at NEJM.org../.../