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Label Changes for:

Avandia (rosiglitazone maleate)Avandamet (rosiglitazone maleate/metformin hydrochloride)Avandaryl (rosiglitazone maleate/glimepiride) Tablets

May 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2011

 

WARNINGS AND PRECAUTIONS

Rosiglitazone REMS (Risk Evaluation and Mitigation Strategy) Program
  • Because of the potential increased risk of myocardial infarction, Avandia is available only through a restricted distribution program called the Avandia-Rosiglitazone Medicines Access Program. Both prescribers and patients must enroll in the program to be able to prescribe or receive Avandia, respectively. Avandia will be available only from specially certified pharmacies participating in the program. As part of the program, prescribers will be educated about the potential increased risk of myocardial infarction and the need to limit the use of Avandia to eligible patients. Prescribers will need to discuss with patients the risks and benefits of taking Avandia. To enroll, call 1-800-AVANDIA or visit www.AVANDIA.com.
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