LEVERKUSEN, Germany and WEST HAVEN, Conn., Sept. 21 /PRNewswire/ -- Bayer was glad to participate in today’s advisory committee meeting held by the Cardiovascular and Renal Drugs Division of the U.S. Food and Drug Administration (FDA). This session provided an open forum in which to discuss the complex scientific issues surrounding the risk/benefit profile of Trasylol(R) (aprotinin injection) in detail.
At the end of the session, the committee overwhelmingly affirmed (18 yes votes and one abstention) that the totality of clinical data presented in today’s meeting supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.
Additionally, as noted in today’s meeting, Bayer has begun discussions with the FDA regarding possible updates to the U.S. Trasylol label. Under consideration are: additional detail to the indication to specify that Trasylol should be used in patients at increased risk for blood loss and blood transfusion and revised guidance with regard to elevations in serum creatinine levels and hypersensitivity reactions in association with Trasylol. Also discussed were additional measures that Bayer could implement to further increase safety around hypersensitivity reactions. These included: additional instructions to physicians concerning administration of the test dose and possible development of a serological (blood) test to determine previous exposure to aprotinin.
Bayer considers the discussion today and the valuable feedback provided by the committee as important guidance and input that will help the company, and the FDA, in clarifying and addressing these critical issues. Bayer will continue to work closely with the FDA and other regulatory authorities regarding changes to the Trasylol label.
About Trasylol
Trasylol, a broad-spectrum proteinase inhibitor, modulates the systemic inflammatory response associated with cardiopulmonary bypass (CPB) in the course of CABG surgery.
Approved by the FDA in 1993, Trasylol is the only product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing CPB in the course of CABG surgery. Full prescribing and warning information is also available at http://www.Trasylol.com.(1)
The effects of Trasylol use in CPB involves a reduction of inflammatory response to surgery, reduced bleeding and decreased re-exploration for bleeding, which translates into a decreased need for allogeneic (blood donated from another individual) blood transfusions.
Important Safety Considerations
Anaphylactic or anaphylactoid reactions are possible when Trasylol is administered. Hypersensitivity reactions are rare in patients with no prior exposure to aprotinin. The risk of anaphylaxis is increased in patients who are reexposed to aprotinin-containing products. The benefit of Trasylol to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis should a second exposure to aprotinin be required (see WARNINGS and PRECAUTIONS in the Trasylol prescribing information).
In clinical studies, hypersensitivity and anaphylactic reactions were: * rare (< 0.1%) in patients with no prior exposure to Trasylol * 2.7% overall reaction rate upon re-exposure -- within 6 months, the incidence was 5 percent -- after 6 months, the incidence was 0.9 percent
Trasylol is generally well tolerated. In clinical trials, graft patency, myocardial infarction, renal or hepatic dysfunction and mortality were comparable to placebo.
(1) Trasylol Prescribing Information. Retrieved August 20, 2004 from
Bayer HealthCare
CONTACT: Meredith Fischer, +1-203-812-6485, Meredith.fischer.b@bayer.com,Dr. Michael S. Diehl, +49-214-30-58532, michael.diehl@bayerhealthcare.com,both of Bayer HealthCare
Web site: http://www.Trasylol.com/
