FDA Warned of Avandia Risks Years Ago

Doctor alerted agency to cardiovascular concerns in 2000
By Sam Gale Rosen,  Newser Staff
Posted May 24, 2007 1:56 PM CDT
FDA Warned of Avandia Risks Years Ago
This undated photo provided by the Cleveland Clinic shows the Cleveland Clinic's cardiology chief, Dr. Steven Nissen. Research by Dr. Nissen has helped keep four dangerous drugs out of the public's hands and this week may have snared another by sounding an alarm on the diabetes drug Avandia. (AP Photo/via...   (Associated Press)

A diabetes doctor warned the FDA of heart risks posed by the diabetes drug Avandia seven years ago, the New York Times reports. The same concerns raised by Dr. John Buse in a 2000 letter were reiterated in a study published by cardiologist Steven Nissen this week.

Documents show that the FDA subsequently reprimanded the drug's maker, GlaxoSmithKline, for minimizing risks. In an interview with the Times, Dr. Buse sticks to his assessment of Avandia, but adds that there should not be a rush to pull it from the market until more studies are completed. “In the last several years, there has not been a study that’s made me feel better about this," he says. (More Avandia stories.)

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