The FDA has decided to restrict the use of the diabetes drug Avandia. The drug will now only be allowed for those patients who have type 2 diabetes that cannot be controlled through the use of other medications.
The controversial drug has been at the center of studies that indicate it can lead to an increased risk of heart problems that include heart attack and stroke, according to the FDA.
Within moments of the FDA’s decision, the European Medicines Agency made an announcement that it will suspend the approval for the drug to be marketed in Europe. Finalizing that decision would remove the drug from the market altogether. The agency’s senior medical officer has said it would reach a decision within a few weeks.
Margaret Hamburg, FDA Commissioner, stated that the agency had carefully gone over the benefits and risks of the drug, and determined a course that would allow the proper clinical care.
Avandia has been used since 1999 to control blood sugar in diabetics. Several studies have been done by independent doctors, GlaxoSmithKline, the FDA and others on the safety of the drug. Most of the results did conclude that there is an increased risk of heart problems when taking the drug.
Dr. Steven Nissen, the author of the original analysis linking the drug to heart attacks, and one of the biggest critics of Avandia use, shared his concern over the length of time it took for the FDA to take this step. However, he also expressed his happiness that these measures would reduce the usage of the drug in the U.S. and Europe to practically nothing.
GlaxoSmithKline has continued to express its faith in the product as a treatment for type 2 diabetics. They stress that are working with the FDA and EMA to follow the actions the agencies require.