It’s now almost certain that Trasylol, an anti-bleeding drug, will stay off the market. A rigorous study found that patients receiving the medication during heart surgery were much more likely to die than patients given other drugs. At press time, Bayer AG, the maker of Trasylol, was still deciding what to do and was awaiting details from the Canadian study. There have already been a number of lawsuits filed claiming Trasylol led to excess deaths and that Bayer hid evidence of harm.
Experts in Canada and the United States say the study appears to seal the drug’s fate, given that several prior studies linked Trasylol to an elevated risk of death after surgery. There were other studies that didn’t find a higher risk, but those had many weaknesses. The latest study was the first head-to-head comparison of Trasylol, also known as aprotinin, and two other drugs that surgeons use to prevent massive blood loss during heart surgery. The findings were released last month by the New England Journal of Medicine. Drs. Wayne A. Ray and C. Michael Stein of Vanderbilt University School of Medicine wrote an editorial accompanying the study. In that editorial, they stated: “In all likelihood, this is the end of the aprotinin story.”
Trasylol was approved in 1993, but questions about its safety didn’t surface until 2006, when one large study linked it to increased risk of death, heart attack, stroke and kidney failure. The Canadian study, paid for by the government, included more than 2,300 patients who were at high risk of bleeding or had multiple health problems. They were chosen randomly to receive Trasylol or two other anti-bleeding drugs during heart surgery. The study was stopped early last October when preliminary results showed a higher rate of death in the Trasylol group. Bayer temporarily pulled the drug off the market two weeks later.
An analysis of the data showed Trasylol increased chances of death by 54%, compared to two other much-cheaper drugs. Six percent of the Trasylol patients died within 30 days of surgery, compared with 4% who got either Amicar or Cyklokapron, despite a slightly lower percentage of the Trasylol patients suffering from massive bleeding or needing transfusions. The researchers found those who died in the Trasylol group had a much higher proportion of heart complications after surgery, including heart attacks. So far, according to Bayer, more than 80 Trasylol lawsuits have been filed. About 200,000 patients worldwide received Trasylol in 2006, the peak year for sales. One has to wonder why the U.S. Food and Drug Administration hasn’t already taken action. Well, on second thought, maybe we don’t have to wonder considering the power and influence of the drug industry and the apparent weakness of the FDA. The agency may even continue allowing the drug to be used in research studies, according to reports.
Source: Associated Press
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