FDA Allows Avandia to Stay Available to Patients

According to a press release from GlaxoSmithKline, the company's type 2 diabetes medicine, Avandia (rosiglitazone maleate), was approved by the U.S. Food and Drug Administration to remain in production.

Although the FDA stated that data regarding the drug may suggest some ischemic risk, they voted nearly unanimously (22 to 1) to keep it on the market. The committee that voted, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, declined to compare it to similar oral anti-diabetic medicines.

Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline said, "We welcome this decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options. Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients."

According to a Medscape article, Avandia, also known as rosiglitazone, may work to improve function of patients with mild Alzheimer's Disease. This was discovered during a study funded by GlaxoSmithKline and the VA Puget Sound Health Care System. GlaxoSmithKline has now launched a larger study in Europe to further study the link between rosiglitazone and Alzheimer's Disease.

There are, however, some risks that have been associated with Avandia. Along with the multitude of side effects listed in the press release (swelling, weight gain, extra fluid, stomach problems, yellowing of the skin), there is evidence that the drug can cause an increase in fractures in female patients. This data comes from a study called ADOPT, where female patients who took the drug consistently received more fractures than those who did not.

The FDA also issued a safety alert regarding Avandia, saying that clinical trials have shown that there is potentially an increased risk of heart attack and heart-related death to patients taking the drug. In the alert, Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research says, "FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia. We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Sources:

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/07-30-2007/0004635550&EDATE=

http://www.medscape.com/viewarticle/483837

http://www.fda.gov/medwatch/safety/2007/Avandia_GSK_Ltr.pdf

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html