Bayer suspends sales of Trasylol

The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final Bart data were available. The Bart study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

This action follows notification to Bayer and regulatory authorities that the Bart executive committee had halted the trial after a planned periodic data analysis indicated not only reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30- day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Bayer has been informed that data are now being collected from centers throughout Canada and a final data analysis will be undertaken by BART investigators.

Once the complete Bart dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated.

Trasylol is contraindicated in patients with a known or suspected aprotinin exposure during the last 12 months.