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Last Updated: Jun 30, 2008 - 11:14:37 AM |
SUNDAY FEB 17, 2008 (Foodconsumer.org) -- A medical researcher said during an interview by CBS Television's 60 Minutes program scheduled to be aired next Sunday that 22,000 patients would not have died if U.S. regulators acted quicker to remove a Bayer AG drug indicated for use to stem bleeding during open heart surgery, Reuters reported Feb 14.
The drug of concern Trasylol was withdrawn in November at the request by the FDA after the agency learned of an observational study showing the medicine was linked to kidney failure requiring dialysis and increased risk of death in those patients.
At a time over the past many years, the drug was given to as many as a third of all heart bypass patients in the United States.
Dr. Dennis Mangano, the study's author, said during the interview he first published a study in January 2006 that linked use of Trasylol with increased death risk and 22,000 lives could have been saved if the medicine was recalled after publishing of his study.
According to Mangano, the German drugmaker had conducted its own research and confirmed the dangers he observed in his study, but failed to disclose to the FDA during an FDA advisory panel meeting in September 2006.
Dr. William Hiatt, the chair of the FDA advisory panel, told CBS 60 minutes he would have voted to remove Trasylol from the market had he known that Bayer had confirmed Mangono's findings, according to a report on the interview published on the CBS website.
Bayer spokeswoman Meredith Fisher was cited by Reuters as saying the company had no comment about the broadcast until it is aired. She said some patients who used the medicine have already filed product liability lawsuits.
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