Starting in November, the type 2 diabetes drugs Avandia, Avandamet, and Avandaryl will no longer be available in retail pharmacies, due to possible heart risks linked to rosiglitazone, an active ingredient in those drugs.
After Nov. 18, 2011, only certain patients will be able to get those drugs, and only by mail order through specially certified pharmacies.
Patients eligible to keep using Avandia, Avandamet, or Avandaryl are those who have already been successfully treated with these drugs or those whose blood sugar cannot be controlled by other diabetes drugs and who, after consulting with their doctor, decline to use the diabetes drugs Actos, Actoplus Met, Actoplus Met XR, or Duetact.
Those are the FDA’s latest rules on the use of rosiglitazone.
This is not a new issue. The FDA issued a safety alert about a possible association between rosiglitazone and increased cardiovascular risks back in 2007 and has been studying the issue for several years.
Last fall, the FDA decided to restrict access to drugs containing rosiglitazone — but not to ban those drugs. That decision followed an FDA advisory panel’s debate in July 2010 about rosiglitazone.
In a statement emailed to WebMD, the drug company GlaxoSmithKline — which makes Avandia, Avandamet, and Avandaryl — says it is “fully committed to patient safety and continues to work with the FDA in the best interest of patients. Patients should be advised to avoid abruptly discontinuing their diabetes medicine without consulting with their physician.”
According to the FDA, around 460,500 U.S. patients filled a prescription for a rosiglitazone-containing product from outpatient retail pharmacies from January 2010 through October 2010.
Prescriptions for rosiglitazone-containing products fell by 50% during that time period, according to the FDA.
SOURCES:
FDA: “FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl.”
WebMD Public Information from the FDA: “Safety Review of Avandia (Rosiglitazone).”
WebMD Health News: “FDA Restricts Avandia.”
WebMD Health News: “FDA Panel Splits Over Avandia Ban.”
News release, GlaxoSmithKline.
