FDA on Rosiglitazone

Posted on May 19, 2011 in News | 0 comments

FDA Finalizes New Restrictions on Rosiglitazone

 

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The U.S. Food and Drug Administration (FDA) just announced new restrictions to the prescribing and use of rosiglitazone-containing medicines to treat type 2 diabetes. These medications are sold under the names Avandia®, Avandamet®, and Avandaryl®. In order to prescribe and receive these drugs, you and your patients must now enroll in a special program.

The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program the FDA may require to manage serious risks of marketed drugs and are based on data suggesting an elevated risk of heart attacks in patients treated with rosiglitazone. The prior REMS consisted of only a Medication Guide. The revised REMS now includes a restricted access and distribution program and applies to all three rosiglitazone products.

The REMS—known as 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 antidiabetic 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 above-noted 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.

FDA is urging patients and their healthcare providers to discuss the advisability of continued rosiglitazone use and to report adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Published on May 19, 2011

Source: FDA drug safety communication: updated Risk Evaluation and Mitigation Strategy (REMS) to restrict access to rosiglitazone-containing medicines including Avandia, Avandamet, and Avandaryl. U.S. Food and Drug Administration Website. http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. Published May 18, 2011. Accessed May 19, 2011.