Anti-bleeding drug Trasylol may
increase mortality risk
30 October, 2007
There is accumulating evidence
suggesting that the drug Trasylol,
manufactured by Bayer AG and used to
prevent excessive bleeding during
heart bypass surgery, increases the
risk of death when compared with other
drugs, according to the United States
Food and Drug Administration (FDA).
The FDA announcement came as a
Canadian study comparing the safety
and efficacy of Trasylol with two
others was halted.
Preliminary results from the Canadian
trial also suggested that Trasylol
increased the risk of death when
compared with the other drugs. The
trial was to include 3,000 patients.
The FDA advised doctors in a notice
posted on its website on October 25,
2007, to be aware of the “accumulating
data suggesting” an increased
mortality risk connected with Trasylol.
The FDA said it would revisit the
drug’s safety, which may include label
changes or other regulatory actions.
Trasylol, also known as aprotinin,
works by blocking enzymes that
dissolve blood clots.
A statement form Bayer AG said it
believes that Trasylol remains a safe
and effective treatment option, but
that the company would work with the
FDA and drug regulators in other
countries to re-evaluate Trasylol’s
risks and benefits and determine where
any label changes are needed.
The FDA said would have to take
unspecified regulatory actions
The US Food and Drug Administration’s
announcement came a month after the
regulator’s advisers recommended that
Trasylol remain on the market despite
its links to an increased risk of
death and other serious side effects.
The FDA approved Trasylol in 1993 to
check the loss of blood and prevent
the need for blood transfusions in
surgeries to bypass clogged coronary
It began re-evaluating the drug’s
safety after the publication in
January 2006 of two studies that
linked the use of Trasylol to serious
side effects, including kidney
problems, heart attacks and strokes.
More recent studies have suggested
that the drug also raises the risk of
death. One of those studies previously
was withheld by Bayer AG from the FDA,
because of what a company
investigation later described as a
“regrettable human error.”