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FDA Date: 5/18/11
FDA Drug Safety Communication for Rosiglitazone-containing Medicines
Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines Including Avandia, Avandamet, and Avandaryl
FDA is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type 2 diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS), a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010.
The REMS, called the Avandia-Rosiglitazone Medicines Access Program, limits the use of rosiglitazone medicines to:
- patients already being successfully treated with these medicines.
- patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies. Patients who are enrolled in the Avandia- Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.