On October 19, 2007, the Data Safety Monitoring Board (DSMB) notified the U.S. Food and Drug Administration (FDA) of its recommendation to stop patient enrollment in a study treatment group of Trasylol. Known generically as aprotinin injection, DSMB said Bayer’s Trasylol may increase the risk of death compared to the antifibrinolytic drugs, epsilon-aminocaprioic acid and tranexamic acid.

In September 2006, the FDA held an advisory meeting, during which Bayer said it had presented all of its information about the drug. The panel voted in support of Trasylol. But days later, a researcher contacted the FDA, stating Bayer hid significant evidence; namely, a review by a Harvard doctor who found Trasylol patients were at an increased risk for kidney failure as well as congestive heart failure, stroke, and death.

Furthermore, a study published in the February 7, 2007 issue of the Journal of the American Medical Association said replacing Trasylol with either adminocaproic acid or tranexamic acid could prevent 10,000 deaths worldwide over the next five years.

According to this newest study, tagged “BART” by DSMB, preliminary data supports findings that suggest aprotinin increases risks for mortality when compared to other antifibrinolytic drugs. The FDA said it “anticipates re-evaluation of the overall risks and benefits of Trasylol…[which] may result in the need to revise the labeling or other regulatory actions.”

Sources: U.S. Food and Drug Administration, “Early Communication about an Ongoing Safety Review Aprotinin Injection (marketed as Trasylol)”; Carla K. Johnson, “Extra deaths add to concern about heart-surgery drug,” Associated Press, February 7, 2007; “Anti-Bleeding Drug Increases Death Risk Following Heart Surgery,” Medical News Today, February 7, 2007; Ed Edelson, “Heart Surgery Drug May Boost Death Risk,” HealthDay News, February 6, 2007; Dennis T. Magano, Ph.D., M.D., et.al, “Mortality Associated with Aprotinin During 5 Years Following Coronary Artery Bypass Graft Surgery (abstract),” Journal of the American Medical Association 297:5, February 7, 2007; Kris Hundley, “Drug warnings fall flat,” St. Petersburg Times, August 5, 2007.