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  • FDA Date: 11/04/2011

    Avandia FDA Drug Safety Communication

    Reminder to healthcare providers and patients regarding Avandia-Rosiglitazone Medicines Access Program

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    The FDA reminds healthcare providers and patients that as of November 18, 2011, rosiglitazone-containing medicines (Avandia, Avandamet, and Avandaryl) are available only by mail order through specially certified pharmacies participating in the Avandia-Rosiglitazone Medicines Access Program. Healthcare providers must enroll in the program 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).

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

    View the full FDA Drug Safety Communication on FDA.gov