Under pressure from medical regulation agencies around the
globe, the manufacturer of Trasylol (generic Aprotinin)
announced on November 5, 2007 that it would remove the
controversial heart surgery drug after a study conducted in
Canada appeared to show an increased risk of death among
patients on whom the drug was used. The drug's maker,
German pharmaceutical firm Bayer AG, has stated that it
still believes the drug to be beneficial. However the study
in question, conducted by the Ottawa Health Institute, had
to be stopped after it appeared that among the heart and
valve surgery patients in the study, though those given
Trasylol had increased risk of death, compared to those
patients given two older antifibrinolytic drugs used in the
study.
Antifibrinolytic drugs such as Trasylol are used during
heart surgery because they slow the breakdown of blood
clots during, and thus can prevent excessive bleeding.
According to the Food and Drug Administration (FDA) there
are not many alternatives when it comes to patients at
risk for excessive bleeding during heart surgery. Thus, the
FDA is working with Bayer to phase Trasylol out of the
marketplace in a way that does not cause shortages of other
drugs used for reducing bleeding during surgery. Therefore,
at this point there will be no complete Trasylol recall.
However, these recent negative findings concerning Trasylol
are only the next in a long line of safety concerns and
warnings that have been documented by the FDA.
In September 2006, Bayer A.G. was faulted by the FDA for
not revealing during testimony the existence of a
commissioned retrospective study that concluded Trasylol
carried potentially greater risks than other similar
antifibrinolytic drugs. The FDA was alerted to the study by
one of the researchers involved. Although the FDA issued a
statement of concern they did not change their
recommendation that the drug may benefit certain
subpopulations of patients. In a Public Health Advisory
Update dated October 3, 2006, the FDA recommended that
"physicians consider limiting Trasylol use to those
situations in which the clinical benefit of reduced blood
loss is necessary to medical management and outweighs the
potential risks" and carefully monitor patients. Due to the
necessity for such drugs in hear surgery, the FDA did not
recommend any withdrawal or Trasylol recall, but did issue
a new Trasylol warning label to strengthen safety warnings
concerning Trasylol.
This trend of potentially dangerous findings concerning
Trasylol illustrates sometimes that once a drug is approved
by the FDA, halting its sale is exceedingly difficult.
Experts on FDA advisory panels are often hesitant to take
widely used medicines out of doctors' hands, even when
their safety is uncertain. For this reason it is important
for anyone who may have had Trasylol used during a surgical
procedure to consult with their doctor about the potential
risks involved. The need for serious consultation
concerning the safety of Trasylol is perhaps even more
important for those who may potentially require Trasylol in
a future surgical procedure.
For anyone who believes that, in addition to a medical
consultation, they might require any kind of legal advice,
contacting an experienced Trasylol law firm may be the best
course of action. A Trasylol lawyer experienced in the
intricacies of the complex situation involved in this case
would be able to offer guidance and information to anyone
who may have been affected, or who may have had a loved one
affected. Getting in touch with an expert Trasylol attorney
can be as easy as filling out the Trasylol lawyer case
evaluation form at the top or bottom of this page. Get
advice you need on any potential Trasylol lawsuit today!
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