FDA Update On Trasylol

On Thursday, October 25th, the Food and Drug Administration (FDA) stated that Trasylol, a drug used during heart bypass surgery to prevent severe bleeding, increases the risk of death as compared to other drugs.

The FDA’s announcement was based on a Canadian study that compared Trasylol’s effectiveness and safety with two other drugs.  Although the study was halted, preliminary results revealed that Trasylol increases the risk of death in patients treated for heart bypass surgery.

Trasylol (generic name aprotinin) works by blocking enzymes that dissolve blood clots.  Bayer maintains that Trasylol is safe and effective, but stated that the company would work with the FDA and regulatory agencies in other countries to determine the drug’s risks, and any necessary label changes.  The FDA said that label updates and other mandatory actions may occur.  (A “black box” warning is the strongest label warning given.)

The FDA began closely re-examining Trasylol’s safety after two January, 2006 studies linked it to kidney problems, heart attacks, strokes and other side effects. More recent studies have suggested the drug also raises the risk of death.  Bayer actually withheld one of those studies from the FDA because of what a company investigation called a “regrettable human error.”

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