Two studies released on Monday reported serious heart risks with GlaxoSmithKline's diabetes pill Avandia as U.S. regulators decide whether the drug should stay on the market.
An analysis of 56 clinical trials found Avandia increased the chances of a heart attack by 28 to 39 percent, researchers at the Cleveland Clinic in Ohio reported in an update to a 2007 study that sparked intense debate about the drug.
Dr. Steven Nissen, the lead author and an outspoken Avandia critic, said the results from more than 35,000 patients gave a more complete picture that reinforced his earlier concerns.
"A drug that increases the risk of heart attack by a third or more in diabetics represents a huge public health burden," Nissen, the Cleveland Clinic's head of cardiology, said in an interview. He said the drug should go off the market.
In another study released on Monday, government researchers said an analysis of more than 227,000 U.S. Medicare patients found Avandia was more dangerous to the heart than a rival pill, Takeda Pharmaceutical's Actos.
Those findings, reported earlier this month by Reuters and others, were published online by the Journal of the American Medical Association. The study's lead researcher is Food and Drug Administration reviewer David Graham, a whistleblower who has argued for years that Avandia is too risky.
Top FDA officials have disagreed, and Glaxo has vigorously defended the drug.
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