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

ardiac surgical patients undergoing either re-operation for coronary heart bypass graft (CABG) or aortic valve replacement, or combined valves or valve/CABG procedures. For information on the BART study, visit: http://www.ohri.ca/programs/clinical_epidemiology/thrombosis_group/studies/BART.as p

About Trasylol

Important Safety Considerations

Trasylol(R) 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(R) 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(R) should be administered only in operative settings where cardio-pulmonary bypass can be rapidly initiated. The benefit of Trasylol(R) 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.)

Safety Considerations

Trasylol is contraindicated in patients with a known or suspected

aprotinin exposure during the last 12 months. Aprotinin may also be a

component of some fibrin sealant products.

-- In clinical studies, hypersensitivity and anaphylactic reactions were rare (<0.1%) in patients with no prior exposure to Trasylol.

Trasylol administration increases the risk for renal dysfunction and

may increase the need for dialysis in the perioperative p
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
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