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Avandia Ordered Off the Shelves in Europe

By October 11, 2010July 9th, 2019Uncategorized

Avandia, the popular drug used to treat Type 2 Diabetes, has been taken off the shelves in Europe among information that links the drug to heart attacks.

In fact, research conducted in 2007 by the Cleveland Clinic shows that the risk of heart attacks increases 43 percent in users of Avandia (generic name: rosiglitazone). It also shows that the risks of suffering a cardiovascular death increased a whopping 64 percent. This information first was published in The New England Journal of Medicine by Dr. Steve Nissen.

What this Means for Americans

In the U.S., regulators have added more restrictions to the use of Avandia for the same reason. The FDA says that patients can only be prescribed Avandia now if their blood sugar levels can’t be corrected with other medications.

“Although the European Medicines Agency went further by actually (suspending) marketing of the drug, both regulatory decisions result in essentially the same outcome — virtually complete elimination of the use of this drug by patients around the world,” says Nissen.

The manufacturers of Avandia, GlaxoSmithKline, stand by the drug.

“The company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes and is now working with the FDA and EMA to implement the required actions,” Dr. Ellen Strahlman, GSK’s chief medical officer, states.

Those actions include putting a severe warning and product box on all drugs that include rosiglitazone. For now, however, GlaxoSmithKline has stopped marketing Avandia as a matter of prudence. The company is not withdrawing the drug, but it is restricting access to it.

Right now, anyone currently taking Avandia is advised not to come off of the drug without the strict supervision of his or her doctor, because stopping can make controlling a diabetic’s sugar levels very difficult. There are other drugs on the market to help with diabetic sugar level control and it is recommended that diabetics attempt to control their sugar through those drugs before taking Avandia.