REMS No Longer Necessary for Rosiglitazone-Containing Diabetes Drugs

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes drugs is being eliminated because it's no longer needed to ensure that the medications' benefits outweigh their risks, the FDA said on Wednesday. These medications include Avandia, Avandamet, Avandaryl, and generic versions.

In 2013, the agency lifted the dispensing and prescribing restrictions on rosiglitazone-containing medications after concluding that the drugs did not confer increased risk for myocardial infarction relative to standard diabetes drugs. The FDA says it's been monitoring the medications since then and hasn't discovered additional safety concerns.