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Trasylol marketing suspended
FDA asked Bayer Pharmaceuticals Corp. to suspend marketing of Trasylol®, used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study suggesting an increased risk for death.
FDA said it asked for the suspension in the interest of public safety based on the serious nature of the outcomes suggested in the preliminary data. The agency said it would work quickly with Bayer and with study researchers and other regulators to undertake a thorough data analysis to better understand Trasylol's risks and benefits.
Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA said it was working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for that purpose. Until FDA can review the data from the terminated study, it said, it is not possible to determine and identify a population undergoing cardiac surgery for which Trasylol's benefits outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA said it is committed to exploring ways for those doctors to have continued, limited access to Trasylol. FDA made the request after being notified that researchers with the Ottawa Health Institute had stopped a Trasylol study because the drug appeared to increase risk for death compared to other antifibrinolytic drugs used in the study. Preliminary study data also suggested fewer patients receiving the drug experienced severe bleeding events. FDA issued an early communication about its ongoing safety review when it first learned of the Canadian study data. It also had revised Trasylol labeling to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.