Heart Surgery Drug Trasylol Confirmed Deadly
A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs. The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.
The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.
During the course of the experiment, 2,331 high-risk cardiac patients scheduled to undergo heart surgery were randomly assigned to one of three anti-bleeding drugs. The rate of death from Trasylol was found to be 6% higher, versus 3.9% and 4% for the other two drugs, Hebert said. The numbers represent a 53% relative risk of dying -- meaning that for every 50 patients treated with aprotinin, one will die -- most as a result of cardiac complications. Due to the significant increased risk of death, the trial was stopped early.
The researchers note that while Trasylol may have a small advantage in reducing massive bleeding, the increased risk of death precludes the use of the drug in patients undergoing high-risk heart surgery.
Despite the drug being pulled off the market in many countries, Bayer AG continues to sell Trasylol in some areas of the world.
The anti-bleeding drug has been marketed and available since 1987, and has been widely used in surgery.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- An earlier announcement by the FDA that marketing of Trasylol would be suspended pending additional safety research
- Growing concern among physicians that drug safety research is suppressed by drug manufacturers
- A new study linking post-surgical female death rates to unnecessary blood transfusions
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