According to a Food and Drug Administration reviewer who worked on a recent study, U.S. government scientists found GlaxoSmithKline Plc's diabetes drug Avandia increased heart risks and deaths compared to Actos, a rival pill.
The findings have not yet been published, but the analysis by U.S. government scientist come only a few weeks ahead of a public meeting on the safety risks of Avandia. At the FDA's meeting in July, an advisory panel will consider data on the drug and could advise recommendations ranging from keeping the drug on the market, to calling for further restrictions, to pulling the product altogether.
In 2007 a study first raised concerns about the drug's cardiovascular effects. Dr. David Graham, author of the recent paper and a known whistleblower, argued in 2007 to an advisory panel of outside experts that Avandia sales should be stopped. The panel voted 22-1 to urge the FDA to keep the drug on the market. Avandia was given a black box warning at that time after a study concluded that people taking Avandia had a 43 percent higher risk of suffering from a heart attack.
In the newest study, Graham and other researchers looked at data on nearly 230,000 Medicare patients and found Avandia increased the risk of stroke by 27 percent, heart attack by 25 percent and death by as much as 17 percent. Graham drew attention to a number of other prescription drugs, including Vioxx, that were later withdrawn or saw strict new warnings.