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December 2, 2008 10:20:29 AM CST

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FDA Delay Cost 22,000 Lives: Doctor

Posted Feb 15, 08 7:53 AM CST in Science & Health 

(Newser) – A prominent researcher who revealed widespread fatalities associated with the heart surgery drug Trasylol says 22,000 people died because of the FDA's delay in blowing the whistle on the drug after his study was published. Drugmaker Bayer also failed to disclose negative results of its own study. In a 60 Minutes interview to air Sunday, Dr. Dennis Mangano says the FDA waited more than a year to pull Trasylol—until after it was banned in Germany.

Mangano's study associated the drug, used to limit bleeding in heart surgery, with kidney failure. In September 2006, when Mangano presented his study to the FDA, Bayer defended the product. and failed to disclose the company's own earlier research, which confirmed Mangano's results. The FDA finally halted sales of Trasylol in November 2007.

Source CBS

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  • Sales of Heart-Surgery Drug Halted

    Nov 5, 07 9:35 PM CST
    Sales of Heart-Surgery Drug Halted Bayer Pharmaceuticals will suspend the sale of Trasylol, a drug used to control bleeding during heart bypass surgery, after a clinical study found that the drug puts patients at increased risk of death, the Washington Post reports. The FDA said sales of the drug would be halted at least until the agency had reviewed the study. More »

The logo of pharmaceutical giant Bayer, manufacturer of Trasylol   (Getty Images)
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global...   (Associated Press)
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global...   (Associated Press)
CEO of German pharmaceutical giant Bayer Werner Wenning addresses a third-quarter results press conference in Leverkusen 06 November 2007. German chemicals and pharmaceutical group Bayer posted a third...   (Getty Images)
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FDA • pharmaceutical companies • heart surgery • Trasylol • Bayer Pharmaceuticals • kidney failure


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