Trasylol Side Effects - 22,000 died amid delayed Bayer drug recall Researcher Says

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 Minutesprogram.

The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those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)