As more and more Americans are diagnosed with Type II diabetes, many turn to medication to manage their condition. Two new studies offer evidence that the diabetes drug Avandia significantly raises the chances of a heart attack, and increases the risk for strokes, heart failure and death. The first study was published by David J. Graham, M.D., M.P.H. of the Office of Surveillance and Epidemiology at the FDA, and the second study was published by Steven E. Nissen, M.D., of the Cleveland Clinic.
GlaxoSmithKline, the manufacturer of Avandia, denies that the studies prove the drug is unsafe.
Avandia was first approved in 1999, and was considered highly effective. However, questions arose over whether it increases the risk of heart problems as outlined in a 2007 report by Dr. Steven E. Nissen, leading the FDA to issue a warning about Avandia’s safety. Sales declined, but Avandia was not pulled from the market.
The new information will be considered at a Food and Drug Administration hearing scheduled for July 13-14, 2010 to reevaluate Avandia’s status. In February, the U.S. Senate Committee on Finance released a report expressing concerns about the safety of Avandia and about FDA oversight, and members of Congress have continued to express concern about Avandia.
More than 4,000 lawsuits have been filed against GlaxoSmithKline alleging Avandia causes heart attacks and strokes in some patients. In May 2010, GlaxoSmithKline reportedly agreed to pay $60 million in the first settlements of the litigation.