Avandia to be Pulled from Retail Pharmacies by November, FDA Says

By November, the diabetes drug <"http://www.yourlawyer.com/topics/overview/Avandia-Heart-Attack-Lawsuit-Lawyer-Attorney-Heart-Failure">Avandia (rosiglitazone) will no longer be available in U.S. retail pharmacies. Patients who are prescribed Avandia will only be able to obtain the controversial medication from selected certified pharmacies via mail order, the U.S. Food & Drug Administration (FDA) announced yesterday. Both doctors and patients will have to meet additional requirements if they want to use Avandia.

The FDA is severely restricting Avandia, citing its heart risks. The FDA actually decided to restrict sales of Avandia last year, after concluding its risks outweighed its benefits. But the agency only announced yesterday how the new rules would be implemented.

Since November 2007, Avandia’s U.S. label has included a black box warning – the FDA’s strongest safety alert – detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increase in the risk of cardiovascular disease. Since 2007, more evidence of Avandia’s heart risks has accumulated. Sales of the drug have already been suspended in Europe, and Avandia’s manufacturer, GlaxoSmithKline, has also stopped promoting it.

In yesterday’s announcement, the FDA said a Risk Evaluation and Mitigation Strategy for Avandia a will take effect November 18. In addition to pulling Avandia from retail pharmacies, the drug will only be available to patients who are already taking it and whose diabetes cannot be controlled with any other medication, or those who do not wish to take an alternative drug called Actos (pioglitazone). In addition, patients and physicians who want to use Avandia must be enrolled in the Avandia-Rosiglitazone Medicines Access Program. Doctors will be required to certify that they have read and understood the rules for using Avandia and agree to explain its risks fully to patients.

In addition to Avandia, the new restrictions will also apply to Avandamet (which contains rosiglitazone and metformin) and Avandaryl (a combination of rosiglitazone and glimepiride).

The new restrictions won’t really affect that many patients. Though it was once the best selling diabetes drug in the world (1 million Americans were taking it by 2006), Avandia sales declined sharply once its association with heart problems was revealed. According to the FDA, as of last October, only 119,000 U.S. patients were taking Avandia.

Since Avandia was linked to a higher risk of heart problems, Glaxo has been named in thousands of lawsuits that claim the drug caused users to suffer heart attacks and strokes. We reported earlier this month that Glaxo has spent $700 million over the last eight months to resolve about 12,000 such lawsuits. In January, the company said it was taking a $3.5 billion charge to cover expenses linked to investigations and suits over Avandia and sales practices on other drugs.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.