Trasylol Labeling Change

The FDA has approved revised labeling for Bayer Pharmaceuticals’ Trasylol (aprotinin) injection to strengthen its safety warnings and to limit its usage to specific situations.  Trasylol is indicated for administration to patients before cardiac surgery to reduce bleeding and the need for blood transfusions.  The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery when also undergoing cardiopulmonary bypass.  The new labeling includes warnings of an increased risk for kidney damage and hypersensitivity reactions, as well as methods to manage and reduce these reactions.