Trasylol now available through investigational protocol only

May 20, 2008

Bayer will remove remaining supplies of Trasylol from market following the publication of negative study results.

Following publication of findings from the BART study in the New England Journal of Medicine’sMay 14, 2008, online edition, Bayer Healthcare Pharmaceuticals has announced the removal of all remaining supplies of aprotinin injection (Trasylol) from hospital pharmacies and warehouses. The antifibrolytic will now be available through an investigational use special treatment protocol only, which will allow for treatment of certain patients at increased risk of blood loss and transfusions during coronary artery bypass graft surgery who have no acceptable alternative therapy. The study, which compared aprotinin to aminocaproic acid and tranexamic acid for post-op bleeding following high-risk cardiac surgery, concluded that the negative mortality trend associated with aprotinin compared with the lysine analogues precludes its use. Under the investigational protocol, prescribers will have to show that the benefits of aprotinin use will outweigh the risks of the treatment for each patient enrolled. Aprotinin has been under worldwide marketing suspension since November 2007.

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