LEVERKUSEN, Germany, Sept. 29 /PRNewswire/ -- Bayer acknowledged today that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology.
Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21st Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the company’s part.
Bayer has submitted a copy of the preliminary report to the FDA and has notified other regulatory authorities. The company is now analyzing this report, answers received from the questions posed to the investigator, and additionally will work with the investigator and other experts to examine the underlying source data and fully understand the results.
Bayer is committed to patient safety. The company will continue to work closely with the FDA to address questions regarding this study and the overall safety and efficacy of Trasylol(R) (aprotinin injection).
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.
Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports file with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) Trasylol Prescribing Information. Retrieved August 20, 2004 from
Bayer Healthcare
CONTACT: Dr. Michael S. Diehl, +49-214-30-58532,michael.diehl@bayerhealthcare.com, or Meredith Fischer, +1-203-812-6485,meredith.fischer.b@bayer.com, both of Bayer Healthcare
Web site: http://www.Trasylol.com/
