New study findings caused Bayer to begin withdrawing supplies of its antifibrinolytic drug, Trasylol (aprotinin injection), from the US market. Trasylol marketing efforts were suspended by the FDA, in November 2007, after preliminary study results suggested increases in the risk of death in patients, compared with two other drugs used to control bleeding, the FDA said in a statement.
The study, Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (dubbed BART), was published in the New England Journal of Medicine (NEJM). According to NEJM, the study found aprotinin to be the most effective hemostatic agent in comparison with lysine analogues. However, “at 30 days, patients who were receiving aprotinin in BART had an increased risk of death of more than 50% … an outcome that led trial investigators to conclude that aprotinin should no longer be used in patients undergoing high-risk cardiac surgery.”
Given Trasylol’s “temporary market suspension worldwide” beginning November 5th, 2007, Bayer doesn’t expect any commercial impact as a result of the NEJM article, according to Staci Gouveia, manager of global communications at Bayer. “On December 17, Bayer HealthCare Pharmaceuticals announced that the company would realign portions of its US marketing and sales force. Driving this realignment was a decision that, independent of forthcoming BART Trial data results, the company would not return to actively promoting Trayslol in the United States and discontinue the promotion of Refludan.”
