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More Evidence Condemns Trasylol and FDA

Posted by Jane Akre
Thursday, February 21, 2008 11:55 AM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Medical Malpractice, Wrongful Death, Product Liability, Defective Drugs, Trasylol

Two new published studies lend weight to the link between the drug Trasylol and kidney failure and deaths.


  • New England Journal of Medicine study, February 21, 2008
  • Injuryboard on Trasylol 

Last Sunday’s 60 Minutes profile of the Bayer AG's Trasylol was a clear condemnation of the drug used to reduce bleeding during heart surgeries. Two new studies offer further evidence that the drug leads to an increase in deaths and kidney failure.

“There continues to be an association between aprotinin (Trasylol) and higher death rates and kidney damage,” says Dr. Andrew Shaw, an associate professor of anesthesiology at Duke University.

Duke is responsible for one of the two latest reports on the drug in the New England Journal of Medicine.

In the study of more than 10,000 people who underwent coronary artery bypass surgery  -  the death rate was higher among the 1,343 who received Trasylol when compared to the more than 2,000 who did not.

And the death rate was higher by 27 percent among those given Trasylol over a competing and standard medication used to limit bleeding, aminocaproic acid.

6.4 percent died within 30 days a rate nearly two and a half times higher than those receiving the other drug or who received no treatment.

The study which followed up on patients for ten years, also found the drug reduced kidney function.

The second study comes of Harvard Medical School and Brigham and Women’s Hospital and was funded by Bayer. In it data from more than 78,000 coronary bypass surgery patients were gathered on patients who used Trasylol and those who were given aminocaproic acid. 

In that study the risk of death was 64 percent higher in the Trasylol group when compared to the other. And an increase in kidney failure leading to dialysis was also found in the Trasylol group.

The FDA had access to this data when it removed Trasylol from the market last November says the study’s lead author, Dr. Sebastian Schneeweiss at Brigham and Women’s. He is uncertain whether there might be any subgroup of patients who actually benefit from Trasylol.

In an accompanying editorial, the message is that when you already have medications that are useful, more studies need to be done before you market the new drug.

“Had this been done 10 years ago with Trasylol, many lives would have been saved” says Dr. Wayne Ray, professor of preventive medicine at Vanderbilt University. #



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