FDA to remove Avandia from retail pharmacies
May 27th, 2011 by Jennifer Walker-Journey
The diabetes drug Avandia will no longer be sold at retail pharmacies beginning in November because of the serious health risks it poses to patients. The Food and Drug Administration (FDA) voted to severely restrict use of Avandia and related drugs last fall after studies showed that users with type 2 diabetes who took the drug were at a 40 percent increased risk of heart attack. Beginning in November, patients will only be able to get the drug by mail order from certified pharmacies participating in a special agency-supported program.
Patients who choose to continue to use the drug must review statements describing the cardiovascular safety concerns associated with Avandia and acknowledge they understand the risks. Their doctors must also attest to and document their patients’ eligibility.
The new rule applies to all drugs containing rosiglitazone, including Avandia , Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimeperide). GlaxoSmithKline, the maker of Avandia, says it will inform pharmacists and doctors about the new program over the next two months. Patients are advised to discuss their diabetes treatment options with their doctors.
More than 23 million Americans are believed to have type 2 diabetes, and nearly 500,000 Americans filled prescriptions for rosiglitazone in the first 10 months of 2010. At that point, prescriptions dropped considerably as news of the restrictions due to health risk were announced.