A study showed that Trasylol, a heart-surgery drug produced
by Bayer AG, raises the risk of death compared to two other competing
medications. As a consequence, the company withdrew its remaining supplies of
the drug from the U.S. market, as Reuters informs.
The statement followed publication earlier on Wednesday of a
Canadian study by the New England Journal of Medicine that showed patients given
Trasylol had a more than 50% higher death rate than patients who got other
drugs. The study found that 6% of
patients who received Trasylol (also called aprotinin), died within 30 days of
surgery compared to 4% of patients who received tranexamic acid or aminocaproic
acid.
The research involved 2,331 patients at 19 Canadian cardiac
centers. Scientists noted that Trasylol is the most efficient at decreasing
massive bleeding, but they think this does not outweigh the risks.
Of the 108 patients
who died, the proportion with "cardiogenic shock, right ventricular
failure, congestive heart failure, or myocardial infarction was higher in the
aprotinin group than in the other two groups," the study said, as cited by
the Wall Street Journal.
The Food and Drug Administration confirmed that Bayer had announced
the agency about what the company is to do as regards Trasylol stocks. Access
to this drug will be limited to investigational use for patients who have no
acceptable alternatives, the FDA said.
"This study could have been done by the company five to
ten years ago," said Dr. Hébert, as
the Journal quotes. He added that Trasylol cost about $1,400 compared to about
$4 for aminocaproic acid.
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