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Bayer Temporarily Suspends Global Trasylol(R) Marketing
Date:11/5/2007

ttp://www.bayerhealthcare.com/trasylol/en" target="_new">http://www.bayerhealthcare.com/trasylol/en, and the German BfArM, U.S. FDA and Health Canada have posted information on their respective web sites.

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 period.

-- This risk may be especially increased for patients with pre-existing

renal impairment or those who receive aminoglycoside antibiotics or

drugs that al
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SOURCE Bayer HealthCare
Copyright©2007 PR Newswire.
All rights reserved

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