FDA Further Restricts Retail Sales of Diabetes Drug Avandia
Due to cardiovascular risk, the US Food and Administration will further restrict the availability of diabetes medications containing rosiglitazone, including the GlaxoSmithKline brand Avandia, after November 18, 2011. The drugs will no longer be available in retail pharmacies and physicians wishing to prescribe the medication will need to enroll their patients in a special registry.
The FDA released a Risk Evaluation and Mitigation Strategy (REMS) document on Wednesday, May 18. The agency noted that it was making the new change “based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.” Avandia, and similar drugs Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride), will be limited to patients who are already being successfully treated with it, as well as patients whose “blood sugar cannot be controlled with other anti-diabetic medications” and who do not wish to use pioglitazone (Actos, Actoplus).
Healthcare providers who decide to prescribe Avandia for their patients will be required to review the prescriber overview and full prescribing information for the drug and sign an enrollment form. A medication guide must be provided to patients and/or caregivers. Physicians should also be aware that if their rosiglitazone patients are hospitalized, they must be enrolled in the Avandia-Rosiglitazone Medicines Access Program registry.
Patients will receive their medication through a mail-order only via specifically designated and certified pharmacies.
According to the FDA, over 460,000 prescriptions were filled for a rosiglitazone-containg product between January and October 2010. Because of the reported risks, the total number of prescriptions has declined and in December 2010, only about 90,000 patients were taking the drug, says Bernadette King of GlaxoSmithKline.
In 2007, an analysis by Cleveland Clinic cardiologist Dr. Steven Nissen showed that Avandia increased heart attack and stroke risk by about 40% in people with type 2 diabetes, who are already much more prone to cardiovascular disease than people without the disease. Subsequent studies confirmed the greater heart attack risk.