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Avandia Restrictions Announced by FDA

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The U.S. Food & Drug Administration (FDA) has restricted the sale of diabetes drug Avandia in retail pharmacies. The agency reported Wednesday that after November 18, the use of Avandia, generically known as rosigiltazone, will only be available to patients via mail order.

In 1999, GlaxoSmithKline introduced the drug to control Type 2 diabetes. By 2006, at least 1 million Americans were taking Avandia, says the Lost Angeles Times, and sales generated more than $3 billion. According to the FDA, from January 2010 through October 2010, about 460,500 patients filled a prescription for Avandia, Avandamet or Avandaryl.

However, in 2007, a study released by cardiologist Dr. Steven Nisser revealed a 40 percent increase of risk developing cardiovascular disease, heart attack, stroke and death among patients taking the drug.

The FDA responded that year by placing a black box warning on the drug’s label alerting users about the risks. Sales immediately fell, says the Los Angeles Times, as of last October about only 119,000 U.S. patients were taking the drug.

As part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA also restricted the sale of Avandamet and Avandaryl. The REMS requires patient enrollment in the Avandia access program to receive the medication. Patients already being successfully treated with the drug can acquire them from specially certified pharmacies participating in the program.

Also, patients whose blood sugar cannot be controlled by other diabetic medications are eligible to receive Avandia, but only after consulting with their healthcare provider.

Physicians must be enrolled in the program to prescribe the drug. They must agree to explain the risks to patients and certify they have read and understand the conditions for use of the drug.

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