The controversial diabetes drug Avandia, known generically as rosiglitazone, will no longer be available in most pharmacies after November, the Food and Drug Administration said Wednesday. Instead, it will be available by mail order only from selected certified pharmacies, and patients as well as physicians will have to undergo educational programs before it can be prescribed, the agency said. The FDA announced in September that it would take this action, but the new rules are just now being implemented.
The blockbuster drug was introduced by GlaxoSmithKline in 1999 and soon became one of the most popular diabetes drugs because of its ability to improve control of Type 2 diabetes. By 2006, at least 1 million Americans were taking the drug and annual sales had climbed to more than $3 billion.
In 2007, however, Cleveland Clinic cardiologist Dr. Steven Nissen published a study showing a 40% increase in the risk of cardiovascular disease, heart attack, stroke and death among those taking it. In 2007, the FDA put a so-called black box warning on the drug’s label cautioning users about the risks, and sales began falling. As of last October, only about 119,000 U.S. patients were taking the drug, the agency said. Most patients who were using it shifted to the related drug Actos, known generically as pioglitazone, which is not believed to cause similar cardiovascular effects.
The new action, implemented under the agency’s Risk Evaluation and Mitigation Strategy, applies not only to Avandia, but also to Avandamet (which contains rosiglitazone and metformin) and Avandaryl (a combination of rosiglitazone and glimepiride). The drugs will be available only to patients who are already successfully using them and whose diabetes cannot be controlled with any other medication, or those who do not wish to take pioglitazone. Physicians who wish to prescribe the drugs and patients who wish to receive them must be enrolled in the Avandia-Rosiglitazone Medicines Access Program. Physicians 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.
The new rules take effect Nov. 18.