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Citing safety concerns, the U.S. Food and Drug Administration (FDA has placed restrictions on the use of GlaxoSmithKline’s Avandia (generic name “rosiglitazone”), a prescription drug that is marketed for treating type 2 diabetes. GSK’s other drugs that contain rosiglitazone, Avandamet (with metformin) and Avandaryl (with glimepiride), have also been restricted. The FDA has proposed requiring manufacturers of rosiglitazone-based drugs to add warnings to the labels and is considering undertaking a Risk Evaluation and Mitigation Strategy program to make sure the drugs are safe. The crackdown comes as a welcome surprise to Takeda Pharma and Merc, makers of Avandia’s main competition, Actos and Januvia.

However, the U.S. is not the only country concerned with rosiglitazone. The European Medicines Agency (EMA) has also targeted the drug for greater regulation and has instituted a marketing ban for any drug that contains the substance. The agency has vowed not to ease restrictions until it is satisfied that rosiglitazone has a positive risk-vs.-reward ratio.

Avandia is no stranger to controversy. In 2007, the New England Journal of Medicine (NEJM) published a study that showed a greater risk of heart attack in those taking Avandia as compared with patients talking other type 2 drugs or with those who weren’t taking any drugs at all. The research revealed that Avandia increased heart attack risk over forty percent and the risk of stroke over twenty-five percent.

After the NEJM study, Some FDA reviewers recommended immediate and permanent removal of the drug from the market. However, because the vote to remove was 8 to 7 in favor of Avandia, the agency refused to take such measures. In compromise, GSK was required to add a warning about heart attacks to Avandia’s label. Avandia’s sales revenues were shaved in half during the two-year period following the publication of the study.

In the United States, Avandia is typically prescribed, along with diet and exercise, in order to improve glycemic function in adults with type 2 diabetes. Rosiglitazone, the active ingredient in Avandia, is a thiazolidinedione that binds to fat cell receptors and makes the cells more responsive to insulin. The result is reduced levels of glucose, fatty acids, and insulin in the blood. An off-label use of Avandia is for treatment of inflammation, which has been shown to benefit those with Alzheimer’s disease, ulcerative Colitis, and malaria.

GSK has also been the subject of close to 13,000 lawsuits related to Avandia; settlement has since been reached in most of the cases. It is estimated that settlements from the suits could reach into billions of dollars. Avandia has also caused some scandal within the FDA itself. The most recent investigation resulted in another vote within the FDA about keeping the drug on the market. The results were mixed: twelve members voted to remove it from the market, seventeen voted to beef up the warning label, and three voted to do nothing. After the vote, however, it was revealed that one of the “do-nothing” voters was actually a paid GSK speaker.

As a result of this most recent spate of trouble, GSK plans to stop marketing the drug world-wide until the issues surrounding rosiglitazone can be settled. Because GSK’s patent on rosiglitazone expires in 2012, it remains to be seen whether the company will continue to expose itself to risk over this very controversial drug.