Less than a month ago, the U.S. Food and Drug Administration (FDA) decided to severely restrict the use of Avandia in diabetes patients. Avandia was approved by the FDA in 1999 and soon after it became the top selling diabetes drug in the world. But in 2007, after Avandia, marketed by GlaxoSmithKline, was shown to cause cardiovascular events such as heart attacks and strokes in patients with diabetes instead of preventing it, drug sales pummeled.
A good number of patients with diabetes die due to heart problems, and antidiabetic drugs like Avandia are supposed to prevent them. With these new restrictions in place, Avandia, just like Accutane, will have to undergo FDA’s stringent monitoring program called Risk Evaluation and Mitigation Strategies (REMS). Health care providers will have to let the patients know about the risks before prescribing the drug.
While US decided to restrict the use of Avandia, the European Union (EU) decided to withdraw the drug from European market.
