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FDA Finally Acknowledges the Risk of Avandia and Removes the Product From Store Shelves

Thursday May 19 witnessed yet another set back aimed in the direction of world renowned pharmaceutical company GlaxoSmithKline (GSK). In a report issued by the U.S. Food and Drug Administration (FDA), officials have confirmed the removal of the controversial diabetes drug Avandia (generic: rosiglitazone) from retail pharmacy shelves because of the dangerous cardiovascular complications associated with it. According to the new regulations, which go into effect on November 18, the medication will only be available to patients who have showed improvement on an Avandia regimen, those who have had no success in controlling their blood sugar with other diabetes medications or patients who have been informed of the risks and still choose to take Avandia.

In their public address, the FDA announced that “Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program”. Accordingly, GSK and any other manufacturer of rosiglitazone-containing products must remove them from pharmacy shelves by November 19.

Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic describes todays events as “a decade-long nightmare coming to an end”. A belief that warranted him to publish a study in 2007 that found that people with type 2 diabetes who took the drug had a 40 percent increase in heart attack risk. However, Dr. Nissen is not alone in his distain towards Avandia. Healthcare providers across the U.S. have publicly announced their dislike of the diabetes medication due to ever-mounting evidence that lends weight to the long-suspected link between Avandia and cardiovascular complications such as heart attack and stroke.

Today’s events should come at no surprise to the healthcare community. Just eight months ago, the FDA announced in a press release that they would severely restrict the use of Avandia and other rosiglitazone products due to the severity of cardiovascular side effects.

Categories: Product Liability
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