In a highly anticipated decision, the widely used diabetes medication Avandia will be pulled from the market entirely in Europe and will now only be available in the United States under tough new restrictions, according to a recent article
in The Washington Post
. As we previously reported here
, the Avandia debate has been a longstanding, contentious issue regarding the pharmaceutical industry and the U.S. Food and Drug Administration’s ability to police its safety. The issue, for years, has been the drug’s potential to increase users’ risks for cardiovascular problems, as there were conflicting reports and studies on the issue.
In our previous post on this issue, we reported that the FDA had said in a February 2010 safety announcement that it would continue to examine studies and data on Avandia health issues before it would take any action with regard to the drug. Since February, according to The Washington Post, both the FDA and European Medicines Agency have concluded that the risk that Avandia could cause heart attacks and strokes outweighs the drug’s benefits for most patients. This decision will have a significant impact–approximately 600,000 diabetics in the United States currently take Avandia.
Starting within the next few months, the drug will be unavailable in Europe. The European agency did, however, stop short of taking the most drastic measure of completely revoking the drug’s approval. Rather, European officials have recommended only suspending the approval, leaving open the option of reinstating the drug if further data on the issue emerge. In the United States, patients will be allowed to take Avandia only if they are not able to control their blood sugar with other medications. As such, doctors who prescribe Avandia will have to justify their decisions to do so. Additionally, patients who want to continue their use of the drug will be required to sign statements indicating that the understand the associated risks. Use of the drug in the U.S. is expected to decline significantly.
According to The Washington Post, the “unusual” coordinated announcement by the U.S. and European drug agencies is representative of the more collaborative relationship between the agencies that has been in place since the 2003 globalization of the pharmaceutical industry. The two coordinated their announcements to attempt to avoid confusion among patients.
Although this announcement stopped short of a total withdrawal of the drug from the U.S. market, it certainly is not good news for its manufacturer, GlaxoSmithKline. The company reportedly
already faced approximately 13,000 lawsuits from plaintiffs who alleged that the maker failed to warn patients of heart attack risks. Although GlaxoSmithKline announced this summer that it had reached settlements in approximately 10,000 of those suits, more are sure to follow on the heels of this announcement.