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Science Forum Index » Medicine - Nursing Forum » 22,000 died amid delayed Bayer drug recall ...
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| Ilena Rose |
 Posted: Fri Feb 15, 2008 6:17 pm |
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http://ilenarose.blogspot.com
Health Lover
http://www.reuters.com/article/newsOne/idUSN1450916820080215
EW YORK (Reuters) - The lives of 22,000 patients could have been saved
if U.S. regulators had been quicker to remove a Bayer AG drug used to
stem bleeding during open heart surgery, according to a medical
researcher interviewed by CBS Television's 60 Minutes program.
The drug Trasylol was withdrawn in November at the request of the FDA
after an observational study linked the medicine to kidney failure
requiring dialysis and increased death of those patients.
It had been given to as many as a third of all heart bypass patients
in the United States at the height of its use over a period of many
years, according to the report.
Dr. Dennis Mangano, the study's researcher, said during the program
that 22,000 lives could have been saved if Trasylol had been taken off
the market when he first published his study in January 2006,
according to a CBS News report on its Web site ahead of a broadcast
slated for next Sunday.
He said in the broadcast that Bayer failed to disclose to the FDA
during an FDA advisory panel meeting in September 2006 -- at which
Mangano's negative findings were discussed -- that the German
drugmaker had conducted its own research which confirmed the same
dangers established by his study.
The chairman of the FDA advisory panel, Dr. William Hiatt, told 60
Minutes he would have voted to remove Trasylol from the market had he
been informed about Bayer's study, according to the CBS report.
Bayer spokeswoman Meredith Fischer said she could not comment about
the broadcast until it is aired, including allegations that the
drugmaker had failed to protect patients.
She said Bayer is facing a number of product-liability lawsuits filed
by patients who had taken the medicine or their families, but said she
not know how many lawsuits were filed.
(Reporting by Ransdell Pierson; Editing by Gary Hill) |
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