January 26, 2006
Study finds kidney risks in Bayer’s Trasylol
Research being published in the New England Journal of Medicine today
concluded that use of Bayer’s Trasylol (aprontin), a standard
treatment to limit blood loss during heart surgeries, were at an
increased risk of kidney failure, heart attacks and strokes, compared
with patients taking alternative drugs, aminocaproic acid and
tranexamic acid, or no drugs at all.
The study of 4,374 patients also found that the cheaper alternatives
to Trasylol were just as effective in limiting blood loss but didn't
cause any of the dangerous side effects associated with the more
expensive brand medication. According to the study, 8% of the 1,295
patients receiving Trasylol suffered kidney dysfunction or required
dialysis, which was twice the rate of the 1,705 patients receiving the
In the first nine months of last year, Trasylol was Bayer's
fastest-growing drug, with global sales of just under $200 million.
Bayer says 150,000 patients received the drug in the US during 2005.
In a statement, the FDA called the study “complicated analysis based
on a large observational database.” The agency said it is working to
gather all available information and to evaluate the drug's safety and
“will make recommendations for best use as soon as possible.”
The Ischemia Research and Education Foundation in San Bruno, Calif., a
nonprofit foundation known for studying heart attacks and strokes,
sponsored the study. The foundation’s chief executive and lead author
of the study, Dennis Mangano, told The Wall Street Journal, the
foundation's funding comes from its endowment, built by doing
clinical-trial work for drug companies in the 1990s. He says the group
no longer does that work for drug companies.