Rosiglitazone-Containing Medications (Avandia, Avandamet, Avandaryl) – Not Associated with Cardiovascular Events – UPDATE
16 December 2015
As of December 16, 2015, FDA no longer requires a Risk Evaluation and Mitigation Stratey (REMS) program for rosiglitazone-containing medications. On November 25, 2013, FDA removed previous restrictions on rosiglitazone use. FDA had announced on September 23, 2010 that rosiglitazone (Avandia) would be restricted to patients with Type 2 diabetes whose diabetes cannot be controlled with other medications. This decision was based on limited evidence that rosiglitazone could be associated with increased risk of cardiovascular events.
The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial is a six-year, ongoing, randomized trial, examining cardiovascular hospitalization or death. RECORD compares rosiglitazone plus metformin or a sulfonylurea to metformin/sulfonylurea combination. A previous evaluation suggested an increased risk of cardiovascular events with rosiglitazone. However, the evaluation had limitations that have been re-evaluated. Although it is still unclear if rosiglitazone has an increased risk in cardiovascular events compared with placebo, the new data suggest no statistical difference in risk with rosiglitazone compared with metformin or sulfonylureas or combinations of these medications.
In 2013, the Risk Evaluation and Mitigation Strategy (REMS) program was modified to require that manufacturers of rosiglitazone provide education to health care professionals. The restrictions on rosiglitazone distribution and required prescriber and patient enrollment in the REMS program were eliminated in 2013. FDA has not identified any safety concerns since the REMS program was modified. Therefore, no REMS program of any kind is required for rosiglitazone.
A joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was held June 5-6, 2013, to discuss cardiovascular safety of rosiglitazone. Additional information about the proceedings of this FDA advisory meeting can be found at the link below.
Additional information is available at the following links:
- Updated Product Labeling and Medication Guide, February 3, 2011:
- FDA MedWatch alerts:
- December 2015
- November 2013:
- February 2011:
- September 2010:
- February 2010:
- November 2007:
- August 2007:
- May 2007:
- December 2015
- FDA Drug Safety Communications:
- Q&A: Avandia (rosiglitazone) - FDA:
- Avandia Related Information – FDA:
- FDA Communication about Ongoing Safety Review:
- Healthcare Professional Information Sheet:
- FDA News releases:
- FDA Advisory Committee recommendations from July 13-14, 2010:
December 16, 2015; November 25, 2013; February 4, 2011; September 27, 2010; July 1, 2010; February 23, 2010; November 15, 2007; June 26, 2007; May 24, 2007; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.