Much debate in the past months has surrounded GlaxoSmithKline’s (GSK) diabetes drug rosiglitazone (Avandia) after it was found that the drug may put patients at a heightened risk for cardiovascular events. Now, healthcare providers prescribing rosiglitazone-containing medications including Avandia, Avandamet and Avandaryl will have to enroll into a special program to prescribe and receive these drugs, according to an FDA safety announcement released May 18.
Last July, members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted that rosiglitazone products stay on the market, but most requested further restrictions or warnings.
The new restrictions come as part of the Risk Evaluation and Mitigation Strategy (REMS) program, which FDA required GSK to establish as part of its September 23 decision.
The FDA revision to the REMS program now includes restricted access and distribution program for rosiglitazone drugs.
The Avandia-rosiglitazone Medicines Access Program will aim to limit the use of rosiglitazone-containing medications to:
- Patients being treated successfully with these medications; and
- Diabetic patients whose blood sugar cannot be controlled with other anti-diabetic medications and who do not wish to take pioglitazone (Actos, Actoplus Met, Actoplus Met XR or Duetact), a drug shown to be a viable alternative to rosiglitazone.
After Nov. 18, the drug will no longer be available through retail pharmacies and patients must be enrolled in the Avandia-rosiglitazone Medicines Access Program to receive medications through the mail.
To enroll, physicians must review prescribing information and complete and sign the prescribe enrollment form and provide patients a copy of the Medication Guide of the drug overview.