FDA Inaction Leads to 22,0000 Patient Deaths From Trasylol, Drug Researcher Claims

David Lowe

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Stay tuned this Sunday for another FDA failure story on 60 Minutes in which Dr. Dennis Mangano, a respected drug researcher, asserts that 22,000 Trasylol deaths could have been avoided if the Food and Drug Administration had paid heed to his published research about Trasylol's dangers, and removed the heart surgery drug from the market two years ago, when his study revealed its widespread association with reports of patient deaths.

The drug Trasylol, manufactured by Bayer AG, was withdrawn in November, 2007 at the request of the FDA after a study linked the medicine to kidney failure requiring dialysis and increased death of those patients. Trasylol, also known as aprotinin, was 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.

Sadly, Dr. Mangano's research was initially vilified by an FDA panel whose chairman had connections with Bayer. "I told you so" provides little solace to families who have lost loved ones due to FDA inaction.