Trasylol (aprotinin) Litigation
CBS News' "60 Minutes" recently ran an excellent piece exposing the corruption and greed of some in the drug industry. Trasylol (aprotinin injection) is used to stop bleeding during heart bypass surgery. It was approved by the Food & Drug Administration in 1993.
A January 2006 New England Journal of Medicine article linked the use of Trasylol (aprotinin) to kidney damage, heart attacks and strokes. In addition, the same researchers completed a February 2007 study published in the Journal of the American Medical Association, which found patients on Trasylol were at greater risk of dying over the next five years than those given two other medications.
In an interview for the "60 Minutes" story, Dr. Dennis Mangano said the FDA should have pulled Trasylol following his NEJM study. "Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," he said in the interview.
The most disturbing part of this is that not until November 2007 did Bayer Pharmaceuticals Corp., the manufacturer of Trasylol, agree to a marketing suspension. The marketing suspension came two weeks after a major Canadian drug trial was terminated because of an increase in deaths for cardiac surgery patients using Trasylol.
The "60 Minutes" story also pointed out there are several other less expensive and safer alternative medications.
A January 2006 New England Journal of Medicine article linked the use of Trasylol (aprotinin) to kidney damage, heart attacks and strokes. In addition, the same researchers completed a February 2007 study published in the Journal of the American Medical Association, which found patients on Trasylol were at greater risk of dying over the next five years than those given two other medications.
In an interview for the "60 Minutes" story, Dr. Dennis Mangano said the FDA should have pulled Trasylol following his NEJM study. "Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," he said in the interview.
The most disturbing part of this is that not until November 2007 did Bayer Pharmaceuticals Corp., the manufacturer of Trasylol, agree to a marketing suspension. The marketing suspension came two weeks after a major Canadian drug trial was terminated because of an increase in deaths for cardiac surgery patients using Trasylol.
The "60 Minutes" story also pointed out there are several other less expensive and safer alternative medications.
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