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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

(Newser) – 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.

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... (Associated Press)

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FDA Warned of Avandia Risks Years Ago

Doctor alerted agency to cardiovascular concerns in 2000

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OTHER STORIES ON OUR RADAR

health • diabetes • GlaxoSmithKline • Avandia • pharma • John Buse

MOST POPULAR STORIES

[ By Views ]

[ By Comments ]

More Newser Stories

Diabetes Drug Ups Heart Risk

New study documents dangers of Avandia, but company nixes recall

FDA Panel Votes to Keep Avandia on Shelves

Controversial diabetes drug still faces heart-attack link

Controversy Rages Over Diabetes Drug's Heart Risks

FDA official says superiors ordered her to back off serious warning

Glaxo Stems Stock Slide Over Avandia

Medical chief rebuts findings on heart risks; claims comparable to other drugs

FDA Panel: Keep Avandia on Market

But it may get warning label on heart risks

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