REMS no longer required to prescribe rosiglitazone

The requirement for prescribers of rosiglitazone to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program has been eliminated by the FDA.

The REMS sponsors are notifying clinicians of this change, which was first announced by the FDA in a November 2013 safety announcement. The change was based on data showing that rosiglitazone-containing drugs (Avandia, Avandamet, Avandaryl, and generics) do not show an increased risk of heart attack compared to metformin and sulfonylureas.

More information about the REMS is available online.