Trasylol - (Aprotinin Injection)

TRASYLOL was first approved on December 29, 1993. APROTININ is the real name and Trasylol is the brand name drug. The active ingredient is Aprotinin Bovine. Trasylol, or aprotinin, aids the body's ability to prevent bleeding. Trasylol works to slow or prevent bleeding, and is used to reduce blood loss and the need for blood transfusion during some types of heart surgeries. Trasylol is made from the lung tissue of cattle. Patients undergoing coronary artery bypass grafting (CABG) using cardiopulmonary bypass may be at risk for bleeding complications due to prior use of anticoagulants or clinical conditions that predispose to bleeding. Trasylol is used to decrease this bleeding risk.

A January 26, 2006 report in The New England Journal of Medicine suggests that Trasylol administration may increase the risk for serious side-effects among some patients undergoing CABG. This report describes the occurrence of serious kidney damage, heart attack (myocardial infarction) and stroke among CABG patients receiving Trasylol. More patients receiving Trasylol experienced these events than patients receiving either no medications intended to decrease blood loss or other medications intended to decrease blood loss. Another recently published study has suggested that patients receiving Trasylol may be at higher risk for kidney damage. This report (published January 20, 2006 in the on-line edition of Transfusion) used methods similar to those used in The New England Journal of Medicine study but included a smaller number of patients. In addition to the previously described studies, one additional study suggested that Trasylol administration may increase the risk for clot formation within coronary artery bypass grafts. In this study, patients receiving Trasylol were compared to those receiving a placebo. The study reported an increased rate of bypass graft closure for patients receiving Trasylol.

On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

On October 19, 2007, the FDA was notified of the Data Safety Monitoring Board�s (DSMB) recommendation to stop patient enrollment in the aprotinin (marketed as Trasylol by Bayer, Inc.) treatment group arm of the: Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.

On November 5, 2007, the FDA announces that Bayer, the manufacturer of Traysolol (aprotinin), will suspend the marketing of this drug until a comprehensive review of a Canadian study showing an increased risk of death can be performed. See FDA News. FDA issued a communication in October, 2007, describing recommendation to stop patient enrollment in the aprotinin treatment group arm of the: Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study.

In pre-marketing clinical studies, Trasylol was administered to approximately 2,000 patients undergoing CABG with cardiopulmonary bypass. In these studies, approximately 1,000 patients received a placebo instead of Trasylol. These studies found that Trasylol decreased the need for blood cell transfusion. The studies did not detect an increased risk for serious kidney or heart side-effects. Certain pre-marketing clinical studies showed that some patients may experience allergic-type reactions to Trasylol, especially patients who receive more than one Trasylol administration. These reactions, including hypersensitivity reactions and anaphylaxis, were rare among patients who received a single Trasylol administration (< 0.1%) but were more common among patients receiving repeat Trasylol administrations (approximately 5% in patients treated within 6 months of prior Trasylol exposure). In general, the serious side effects described in The New England Journal of Medicine report are the type of reactions that occur within days following CABG. Patients are unlikely to experience these side-effects from Trasylol after this time period.

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