End for Anti Bleeding Drug, Trasylol
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In November of 2007, after initial reports were given to the Food & Drug Administration (FDA) Bayer AG, the maker of the drug Trasylol (also know as aprotinin), agreed to temporarily suspend sales and marketing of Trasylol. The New England Journal of Medicine released the results from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study. The BART study compares Trasylol and two other alternative drugs that surgeons use to reduce bleeding. Compared to the alternatives, the study noted Trasylol had a significant absolute increase of 2.1%, or a relative increase of 54% in the number of deaths. Six percent of the Trasylol patients died within 30 days of surgery, compared to 4% with patients who received Amicar or Cyklokapron. These patients died from kidney failure, heart attack, and stroke. The bottom line, patients getting Trasylol during heart surgery were much more likely to die than patients given other drugs.
The authors of the BART study, terminated it early due to ethical concerns raised after the research showed that Trasylol doubled the risk of death versus the alternatives. According to lead researcher Dean A. Ferguson, a transfusion medicine expert at the Ottawa Health Research Institute:
“There was no way we could ethically enroll more patients in the trial because we had our answer.”
An accompanying editorial to the study stated that:
“In all likelihood, this is the end of the aprotinin story.”
In 2006, the peak year for sales, about 200,000 patients worldwide received Trasylol. Bayer is facing more that 80 lawsuits over this dangerous drug.