The Committees also recommended that Bayer amend the U.S. product label for Trasylol to provide additional prescribing guidance to physicians and also recommended that Bayer conduct additional clinical studies, including randomized controlled trials, to further assess the risk and benefit of Trasylol.
Bayer was pleased to participate in today's session because it provided a proper forum in which to discuss the complex scientific issues surrounding the risk/benefit profile of Trasylol in detail. Trasylol is the only drug currently approved by the FDA for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Patient safety is Bayer's first and foremost concern. In line with the discussions and guidance received from the Committees today, the company will work with FDA on appropriate U.S. label revisions providing additional prescribing guidance to physicians.
The Committees also recommended that Bayer undertake additional clinical studies, including randomized controlled clinical trials, to further assess risks and benefits of Trasylol. Following the Committeesâ recommendation, Bayer will move forward with discussions with the FDA to reach agreement with them regarding further clinical activities.
Bayer is in close contact with other regulatory authorities around the world and will inform them of the outcome of todayâs meeting and potential next steps.
Bayer considers the discussion today and the valuable feedback provided by the Committees as important guidance and input that will help the company in clarifying and addressing these critical issues. Bayer continues to believe that the totality of the medical evidence, including the RCTs and other data discussed today demonstrates that Trasylol is safe and effective when used according to the product labeling. Bayer will continue to work closely and cooperatively with all regulatory authorities to address questions regarding safe and effective use of its drugs.
Important Safety Considerations
Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol® administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Trasylol® should be administered only in operative settings where cardio-pulmonary bypass can be rapidly initiated. The benefit of Trasylol® to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the prescribing information.)
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