FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations
06-203
December 15, 2006
The U.S. Food
and Drug Administration (FDA) today approved
revised labeling for Trasylol (aprotinin injection)
to strengthen its safety warnings and to limit
its approved usage to specific situations. Trasylol
is given to patients before heart surgery to
reduce bleeding and the need for blood transfusions.
Trasylol is marketed by Bayer Pharmaceuticals
Corporation, Leverkusen, Germany.
"The purpose of the label change is to
inform physicians and patients about the risks
associated with Trasylol and to ensure they understand
the new warnings and use the product as directed
by the label," said Steven Galson, M.D.,
MPH, Director of FDA's Center for Drug Evaluation
and Research.
The new labeling specifies that Trasylol should
only be given to patients who are at an increased
risk for blood loss and blood transfusion in
the setting of coronary bypass graft surgery
(a procedure used to improve blood flow to the
heart) when patients undergo cardiopulmonary
bypass (a procedure that allows a machine to
take over the heart's functions when it is stopped
during surgery). The changes also include a warning
that Trasylol increases the possible risk for
kidney damage, and suggest ways to manage and
reduce the patient's risk for hypersensitivity
(exaggerated immune) reactions.
The labeling changes follow an FDA-conducted
review of safety information that FDA became
aware of after the product was introduced to
the market. FDA began this safety review of Trasylol
in January 2006. The review was triggered by
the results of two published research studies.
One study reported an increase in the possibility
of kidney failure, heart attack and stroke in
patients treated with Trasylol compared to those
treated with other drugs. The other study reported
an increase in the possibility of kidney damage
compared to other drugs, but did not show an
increased risk of heart attack or stroke. On
February 8, 2006, FDA issued a Public Health
Advisory regarding these new findings with Trasylol.
On September 21, 2006, FDA held a public meeting
of the Cardiovascular and Renal Drugs Advisory
Committee to discuss the safety and overall risk-benefit
profile for Trasylol. At that meeting, the committee
discussed the findings from the two published
observational studies, a Bayer worldwide safety
review, and the FDA review of its own post-marketing
database, and made recommendations for labeling
changes. The labeling changes for Trasylol are
based upon the recommendations of that advisory
committee.
FDA announced on September 29, 2006, that Bayer
informed the agency of an additional safety study
on September 27, 2006. The preliminary results
from that study suggest that in addition to serous
kidney damage, Trasylol may increase the chance
for death, congestive heart failure (a weakening
of the heart), and strokes. The FDA review of
this additional Trasylol safety information is
continuing and it may result in other actions,
including additional changes to the labeling.
For additional information about Trasylol, see
www.fda.gov/cder/drug/infopage/aprotinin/default.htm.
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