 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial
|
FOR IMMEDIATE RELEASE |
Media
Inquiries: |
The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.
"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."
FDA advises health care providers to be aware of the following:
Trasylol (aprotinin injection) is the only product approved by FDA for the
prevention of peri-operative blood loss and the need for blood transfusion
among patients undergoing coronary artery bypass graft surgery. The drug
aids the body's ability to stop bleeding and is used to lessen the bleeding
risk during this surgical procedure. This surgery is done to bypass clogged
arteries.
.
FDA is evaluating the studies more closely, along with other scientific literature
and reports submitted to the FDA through the MedWatch program, to determine
if labeling changes or other actions are warranted. One study, published
in the New England Journal of Medicine, reported that patients who received
Trasylol had higher rates of serious kidney problems, heart attacks, and stroke
compared to treatment with other drugs to prevent bleeding or to no treatment;
the second study, reported in Transfusion, reported more cases of decreased
kidney function in patients treated with Trasylol compared to another treatment
to prevent bleeding. A limitation of both studies was that doctors chose
which patients were to receive Trasylol or another treatment. It is
possible that patients treated with Trasylol may have been sicker than other
patients. The studies used complex statistical methods to adjust for
possible differences in patient risk factors.
The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of Trasylol, and if additional safety measures need to be taken. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.
FDA also urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1800-FDA-1088), by fax (1-800-FDA-1078) or internet.
The Public Health Advisory is available on line at http://www.fda.gov/cder/drug/advisory/aprotinin.htm.
For more information please visit http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm,
####
RSS Feed for FDA News Releases [what's this?]
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.