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FDA says no to Avandia in drugstores

Consumer Reports News: May 20, 2011 01:13 PM

You won’t be able to get the type 2 diabetes drug Avandia (rosiglitazone) in pharmacies after November 18. That’s when new Food and Drug Administration restrictions will take effect, with the aim of reducing the risk of heart attacks caused by the medication. Instead, you’ll have to enroll in a special program to get rosiglitazone and combination products that contain it by mail order.

Last year, the FDA limited the use of Avandia, Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride) to people already on one of those medications and those whose diabetes is not controlled by other drugs. The new restrictions announced this week require both patients and doctors to enroll in the Avandia-Rosiglitazone Medicines Access Program. Certified pharmacies will deliver the medications by mail order to eligible patients.

Bottom line: We have long said that rosiglitazone carries too many risks and should be avoided if possible. Instead, we recommend the drug metformin, either alone or with glipizide or glimepiride, as your first option. Metformin has a well-established safety profile and it is available as a very inexpensive generic. For details, see our Best But Drugs Report on diabetes drugs as well as our advice on how to diagnose and treat it.

FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl [U.S. Food and Drug Administration]

Steve Mitchell

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