Avandia, Avandamet, and Avandaryl to be Removed from Retail Pharmacies

The FDA announced that after November 18, 2011, the diabetes drugs, Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), and Avandaryl (rosiglitazone/glimepiride) will be withdrawn from retail pharmacies by GlaxoSmithKline. In order to prescribe and receive these drugs, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program. The program limits the use of rosiglitazone medicines to patients already being successfully treated with these medicines, and those whose blood sugar cannot be controlled with other anti-diabetic medicines and who do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).  Patients who are enrolled in the program will receive their medicine by mail order through specially certified pharmacies participating in the program.

On September 23, 2010, FDA announced that it would significantly restrict the use of rosiglitazone medicines to patients with type 2 diabetes who cannot control their blood sugar on other medicines. These new restrictions were instituted in response to data that suggest an elevated risk of heart attacks in patients treated with rosiglitazone.  

From January 2010 through October 2010, around 460,500 patients filled a prescription for a rosiglitazone-containing product from outpatient retail pharmacies.  The projected number of patients filling a rosiglitazone-containing product declined by 50% from 235,500 patients in January 2010 to around 119,000 in October 2010.

For more information visit www.fda.gov/Drugs/DrugSafety/ucm255005.htm