FAQ - Frequently Asked Questions Regarding Trasylol
The following are frequently asked questions regarding the medication
Trasylol:
FAQ:
1. What is Trasylol and what is it used to treat?
Trasylol, or aprotinin, a product derived from bovine lung tissue, inhibits
certain enzymes that increase the risk for bleeding. Trasylol administration
aids the body's ability to prevent bleeding.
Patients undergoing
coronary artery bypass grafting (CABG) using cardiopulmonary bypass may be at
risk for bleeding complications due to prior use of anticoagulants or clinical
conditions that predispose to bleeding. Trasylol is used to decrease this
bleeding risk.
2. What is the concern
regarding Trasylol?
A January 26, 2006 report in The New England
Journal of Medicine suggests that Trasylol administration may increase the risk
for serious side-effects among some patients undergoing CABG. This report
describes the occurrence of serious kidney damage, heart attack (myocardial
infarction) and stroke among CABG patients receiving Trasylol. More patients
receiving Trasylol experienced these events than patients receiving either no
medications intended to decrease blood loss or other medications intended to
decrease blood loss.
Another recently published study has suggested that patients receiving
Trasylol may be at higher risk for kidney damage. This report (published January
20, 2006 in the on-line edition of Transfusion) used methods similar to those
used in The New England Journal of Medicine study but included a smaller number
of patients.
3. Did the patients who developed these serious
side-effects have other possible reasons to develop these reactions?
It is not known if the patients receiving Trasylol in The New England
Journal of Medicine report were sicker and thus at higher risk prior to
receiving Trasylol than the patients in the other study groups. The study report
authors used statistical procedures to try to adjust for this consideration. In
the Transfusion report, the patients seemed to be similar in both study groups.
4. Have other studies indicated problems with Trasylol?
In addition to the previously described studies, one additional study
suggested that Trasylol administration may increase the risk for clot formation
within coronary artery bypass grafts. In this study, patients receiving Trasylol
were compared to those receiving a placebo. The study reported an increased rate
of bypass graft closure for patients receiving Trasylol.
5. What are
the strengths and limitations of The New England Journal of Medicine Report when
compared to other reports?
The major strength of The New England
Journal of Medicine study is the collection of information from a large
number of patients who were managed according to common medical practice.
The major limitation of The New England Journal of Medicine study is
that patients were not randomly assigned to any of the treatments (or to no
treatment) for preventing bleeding. The treating physicians determined, based on
their experience and judgment, whether to administer Trasylol, another drug to
prevent bleeding, or no treatment. It is possible that the treating physicians
may have chosen to administer Trasylol only to the sicker patients while the
less sick patients received other products or no therapy to prevent bleeding.
Consequently, the study outcomes may not truly indicate Trasylol side-effects.
Instead, the study outcomes may indicate the seriousness of the underlying
condition of the patients chosen to receive Trasylol. It is important to note
that the study investigators used statistical analyses to try to correct for
this limitation.
In clinical studies where the choice to use Trasylol or
not was decided by chance alone, Trasylol administration was not associated with
the detection of any increase in the risks for the serious side-effects
described in The New England Journal of Medicine report. These types of studies
were performed in order to rigorously detect the Trasylol effects. However,
these studies also have limitations; for example, the patients enrolled in the
study may not truly reflect all types of patients undergoing CABG and the other
cardiovascular therapies used in the studies may differ from those routinely
used in medical practice. These considerations are especially important when
clinical advances may rapidly change the practice of medicine.
If you experienced kidney failure after being administered Trasylol, please complete the form below. A representative of our firm will be in touch shortly.
see also:
Trasylol News
Updated News on the Harmful Health Risks Associated with TrasylolGet Trasylol news and a free legal review of your case from a lawyer
Learn More
Learn more about the FDA Trasylol alert from an experienced lawyerHealth Alert: Learn about the FDA Advisory for Trasylol from a lawyer
Research Center
Serious Risks Associated With Trasylol and Heart Surgery. Lawyers InfoResearch Trasylol and get lawsuit information from Trasylol lawyers
