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Bayer Issues Additional Guidance to Physicians on Trasylol(R)
Date:10/25/2007

, when deciding to prescribe Trasylol, physicians should also take into consideration that the BART Trial has been halted due to an increase in all-cause mortality in patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.

Patient safety remains Bayer's primary concern. Bayer believes Trasylol remains a safe and effective treatment option for physicians. Bayer will continue to work closely with medical experts, the FDA and health authorities in countries where Trasylol is marketed to re-evaluate the overall risk-benefit of the product and will evaluate the need for a label change and/or other actions as additional data and analyses become available from the BART trial.

Bayer has posted information regarding this issue on its websites http://www.trasylol.com, http://www.pharma.bayer.com, http://www.bayerscheringpharma.de/trasyslol/en, http://www.bayerhealthcare.com/trasylol/en. Subsequently, in consultation with the FDA and other health authorities, the Company will issue a letter to health care providers who use Trasylol such as cardiothoracic surgeons, anesthesiologists and hospital pharmacists. Bayer has also been informed that the FDA plans to communicate with the public on this issue.

About BART

According to information on the website of the Ottawa Health Research Institute (Institut de recherche en sante d'Ottawa), the BART study -- Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients -- is a multi-institutional, blinded, randomized controlled trial to compare the efficacy and safety of the use of aprotinin, aminocaproic acid and tranexamic acid in approximately 3000 high-risk c
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
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