Diabetes Drug Avandia Unavailable in Retail Pharmacies after November

Avandia, the controversial diabetes drug introduced by GlaxoSmithKline in 1999, will no longer be available in retail pharmacies after this November. The FDA announced in September that it would take this action after a study showed Avandia was associated with increased cardiovascular risks. New rules governing the distribution and prescription of Avandia are now being announced.

In a 2007 study, cardiologist Dr. Steven Nissen found that Avandia caused a 40 percent increase in the risk of cardiovascular disease, heart attack, stroke and death among those taking it. Following up on Nissen’s study, the FDA put a black-box warning on the drug cautioning users about its risks. Use of Avandia dramatically declined after this action, with only 119,000 U.S. patients using the drug (as compared to the estimate of a million patients taking Avandia in 2006).

The new action limiting Avandia’s use is being implemented under the agency’s Risk Evaluation and Mitigation Strategy. Avandia will only be available to patients who have already been using it successfully and whose diabetes cannot be controlled by any other drug. Physicians who wish to prescribe the drugs and patients who wish to receive them must be enrolled in the Avandia-Rosiglitazone Medicines Access Program. Additionally, they must certify that they have read and understood the conditions for use of the drugs and agree to explain the risks fully to patients.

Patients who are enrolled in the program and who are hospitalized will be able to receive the drugs in the hospital, but hospitals will not have to enroll in the program.

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