FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued 11-25-2013.

This is an update to the FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl issued on May 18, 2011.

[11-04-2011] The U.S. Food and Drug Administration (FDA) is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medicines (Avandia, Avandamet, and Avandaryl). After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies and will only be available by mail order through specially certified pharmacies participating in the program.

Healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program (access the REMS) if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities. Healthcare providers must also enroll eligible patients in order for the patients to begin or continue to receive rosiglitazone medicines. Enrollment information is also available on the Avandia website (www.avandia.com). 

Patients should schedule an appointment with their healthcare provider as soon as possible to determine if it is appropriate for them to continue taking a rosiglitazone medicine and, if it is, to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. 

FDA previously communicated about the restrictions to the prescribing and use of rosiglitazone medicines in the May 18, 2011 Drug Safety Communication.

Related Information

• FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines
• FDA Drug Safety Podcast for Healthcare Professionals: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program
• FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
• Avandia-Rosiglitazone Medicines Access Program
• Avandia - Rosiglitazone Medicines REMS
• Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information