The U.S. Food & Drug Administration (FDA) has finally announced how and when it will implement new restrictions for Avandia and other diabetes drugs containing rosiglitazone. Because of the new restrictions, Avandia will no longer be available at retail pharmacies after November 18.
The new restrictions are being put in place because the FDA has determined that Avandia’s heart risks outweigh its benefits for most patients with Type II Diabetes. The new restrictions will also apply to Avandamet (which contains rosiglitazone and metformin) and Avandaryl (a combination of rosiglitazone and glimepiride).
The new Avandia restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS). According to the FDA, the REMS 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).
In order to prescribe or use Avandia, doctors and patients will need to enroll in the Avandia-Rosiglitazone Medicines Access Program. Patients enrolled in this program will receive their medicine by mail order through specially certified pharmacies, the FDA said. Enrollment information is available on the Avandia website.
The FDA decided last September that it would restrict Avandia and other rosiglitazone medicines in response to data that suggest an elevated risk of heart attacks in patients treated with rosiglitazone. Since November 2007, Avandia’s U.S. label has included a black box warning – the FDA’s strongest safety alert – detailing its heart risks. The black box was added after a 2007 study showed that patients taking Avandia faced a 40 percent increase risk for heart attacks.
A spokesperson for GlaxoSmithKline, the maker of Avandia, told Bloomberg News that the company plans to begin informing pharmacies about the drugs’ new restrictions within 60 days, and implement the changes before the November deadline.