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TORONTO — The U.S. Food and Drug Administration has revealed that the safety board overseeing a large Canadian-led trial has recommended the trial be stopped because of concerns the drug being tested increases the risk of death.
The FDA statement says that the Data Safety Monitoring Board has recommended no new patients be enrolled in the trial.
The study, which goes by the acronym BART, is led by Ottawa researcher Dr. Paul Hebert.
It was designed to test the drug aprotinin — marketed as Trasylol by Bayer Inc. — against other drugs used to reduce blood loss during heart bypass surgery.
The FDA statement says that compared to the other drugs, aprotinin seems to increase the risk of death.
Hebert, a researcher with the Ottawa Health Research Institute, was not immediately available for comment.
The statement says the FDA hasn't yet concluded whether the new information requires it to take regulatory action against the drug.
The FDA has been studying the safety of aprotinin, looking into suggestions it may also increase chances of kidney failure, heart attack and stroke.
An expert panel convened by the U.S. drug regulator voted in mid-September to recommend that the drug stay on the market.
