–January 26, 2006
A recent study shows the drug Trasylol-commonly given to reduce bleeding during heart surgery-can double the risk of renal failure, stroke, heart attack, and death. This study, appearing in the New England Journal of Medicine , indicates that people given Trasylol during coronary-artery bypass surgery were two times more likely to suffer these serious adverse reactions, compared to heart surgery patients not given Trasylol.
Trasylol (aprotinin) is a serine protease inhibitor used during heart surgery to reduce bleeding. While the FDA approved Trasylol in 1993, researchers note that pre-marketing studies were not thorough enough to detect the rare risk of serious complications.
This Trasylol heart surgery study involved over 4,300 patients at 70 medical institutions worldwide.
The study found that Trasylol use doubled patient’s risk of renal failure, heart attack, heart failure, stroke, brain disease, and overall risk of death.
In the Ischemic Research and Education Foundation’s research, some subjects were given alternative medications to reduce bleeding: aminocaproic acid and tranexamic acid. Neither of these generic medications were associated with an increased risk of serious adverse reactions and death.
The study’s authors concluded that, “Our findings indicate that reconsideration of the safety of aprotinin among patients undergoing cardiac surgery is warranted and indicate replacement of aprotinin with either aminocaproic acid or tranexamic acid .”
They added that the generic alternatives to Trasylol are less expensive.
For years, medical professionals have been concerned about Trasylol side effects and serious adverse reactions. “Yet, until [this] report, sufficient data had not been available for an analysis of the risks and benefits of aprotinin,” says Dr. Gus Vlahakes of Harvard Medical School.
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