The U.S. Food and Drug Administration (FDA) has announced it is removing certain restrictions on prescribing and use of rosiglitazone (Avandia) to reflect new information regarding the cardiovascular risk of the medicine.

The FDA's actions include requiring modifications to labeling about cardiovascular safety, requiring changes to the Risk Evaluation and Mitigation Strategy (REMS) program, and releasing a postmarket study requirement.

According to the FDA, once the changes are final, rosiglitazone's indication for use will no longer be limited to certain patients. The agency anticipates the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.

"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."

In announcing the decision, the FDA highlighted results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) Trial that showed no elevated risk of heart attack or mortality in patients being treated with rosiglitazone when compared to standard-of-care diabetes drugs. "These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007," the agency said.

The decision is consistent with the recommendations of expert advisory committees. In June 2013, the FDA Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended modifying current restrictions on rosiglitazone.

Keywords: Risk, Myocardial Infarction, United States Food and Drug Administration, Blood Glucose, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diet, Advisory Committees, Thiazolidinediones, Drug Evaluation

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