FDA Drags Feet On Bayer Recall, 22,000 Dead

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The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those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

Bayer is facing a number of product-liability lawsuits filed by patients who had taken the medicine or their families.


 

 

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