Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration

Abstract

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 . . .