LEVERKUSEN, Germany, Jan. 25 (UPI) -- German firm Bayer said Thursday it has halted its studies to test Trasylol for uses beyond its approved indication for use in cardiac bypass.
Bayer's drug is currently approved in the United States and other markets for reducing blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery (CABG) in patients at a higher risk for blood loss and blood transfusion.
But the company said it had been conducting three additional trials to assess Trasylol for the same use in patients undergoing other procedures like elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.
Bayer said its decision to discontinue the non-CABG trials was not based on any safety signals seen in the studies, but noted that after a board overseeing the trials reviewed data on the first 120 patients in November, it concluded "these three clinical trials could continue as planned without modification."
Bayer said Trasylol is the only drug currently approved to reduce blood loss and the need for blood transfusion in CABG patients.
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