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Bayer Discontinues Trasylol Study

Posted on: Friday, 26 January 2007, 09:00 CST

Bayer has decided to end three studies investigating the safety and efficacy of its heart drug Trasylol on transfusion requirements and blood loss in adults undergoing a number of surgical procedures.

The studies, designed to expand the use of the drug, included examining the effectiveness of the drug in patients undergoing elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.

Bayer said that it dropped the studies following a labeling change which includes a recommendation that in order to manage possible anaphylactic reactions, Trasylol should be administered only in surgical settings where cardiopulmonary bypass (CPB) can be rapidly initiated. Bayer said that the use of CPB is not practical in non-cardiac surgical settings.

Bayer added that its decision to discontinue the trial was not based on any safety findings in these studies.

Trasylol is the only drug approved to reduce blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.

"We believe that Trasylol can continue to provide important benefits for CABG surgery patients and, therefore, fills an important role for their cardiac surgeons," said Dr Paul Mac Carthy, vice president, Medical Affairs Bayer Pharmaceuticals Corporation.

Source: Datamonitor

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