Back to Trasylol®

Trasylol® manufacturer Bayer has decided to end three ongoing clinical studies investigating the safety of Trasylol® (aprotinin) in patients undergoing elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.

The Trasylol® labeling that was recently updated by the Food and Drug Administration (FDA) includes a recommendation that in order to manage possible anaphylactic reactions, Trasylol® should be administered only in surgical settings where cardiopulmonary bypass can be rapidly initiated.

Bayer's decision to discontinue these Trasylol® trials was not based on any safety findings in these studies.

Trasylol® is currently the only drug approved by the FDA to reduce blood loss and the need for blood transfusion in patients undergoing coronary artery bypass grafting (CABG) surgery.

About Trasylol®

Trasylol® is used to reduce blood loss and the need for blood transfusion in patients undergoing CABG surgery. The effects of Trasylol® involve a reduction in systemic inflammatory response to surgery, which translates into a decreased need for blood transfusions.

Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with a test dose as well as the regular dose regimen. Fatal reactions to Trasylol® have also occurred in situations where the test dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. The benefit of Trasylol® to patients undergoing CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin.

If you or someone you know has undergone a coronary artery bypass grafting surgery and subsequently developed the onset of kidney failure, please use the form on the left to contact our law firm.

Reference:

"Bayer Discontinues Trasylol® Clinical Trial Program In Non-CABG Indications," medicalnewstoday.com, January 2007.