22,000 died amid delayed Bayer drug recall: doctor

-Reuters

02/15/2008 —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The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those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.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits fill out our free Trasylol case evaluation . Our on-staff nurse and attorneys are standing by to answer any questions you may have regarding Trasylol side effects, a possible Trasylol class action lawsuit, or any other type of Trasylol litigation.