Trasylol (Aprotinin)

Trasylol (Aprotinin) was manufactured by Bayer Pharmaceuticals Corporation and was approved by the Food and Drug Administration (FDA) in December 1993 to reduce bleeding and the need for blood transfusion in patients undergoing heart surgery. On November 5, 2007, the FDA announced that Bayer had agreed to the suspension of Trasylol pending further evaluation of studies indicating increased risks for adverse events in patients. Trasylol has been linked to increased risk for patient death, kidney failure, heart attack, and stroke during and immediately after open-heart surgery.

Bayer announced in November 2007 that it was halting worldwide sales of Trasylol, a blood clotting agent used in heart surgeries. Already under intense scrutiny, Trasylol was pulled after an Ottawa-based clinical trial was abruptly stopped when researchers found that Trasylol could be linked to a higher risk of death than similar, cheaper drugs made for the same purpose.

Known generically as aprotinin, Trasylol was used to prevent excessive bleeding during open-heart surgery. Introduced in 1993, it has come increasingly under the microscope since January of last year when safety concerns indicated it increased the risk for heart attack, kidney complications and stroke.

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