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Trasylol (aprotinin) injection

9 November 2007

On 6 November 2007, Bayer Australia Ltd announced a worldwide suspension of the supply of Trasylol (aprotinin) injection. This follows the release of preliminary results from the BART clinical trial that suggested an increased risk of death for patients receiving Trasylol (aprotinin) compared to those receiving the alternative medications of aminocaproic acid or tranexamic acid for control of bleeding during heart surgery.

Trasylol is registered in Australia to reduce the risk of blood loss and reduce the need for blood transfusion in adults undergoing cardiopulmonary bypass for coronary artery bypass graft surgery where the risk of bleeding is high or where blood transfusion is unavailable or unacceptable. Aminocaproic acid and tranexamic acid injections are not registered in Australia. However tranexamic acid injection has some use under the Special Access Scheme for individual patients.

The BART clinical trial was a randomised, controlled trial in cardiac surgery patients in Canada. It was halted early due to safety concerns. The information on this trial is limited and preliminary at this stage. Once the full data are available, the TGA, along with other regulatory agencies, will review the findings and reassess the risk benefit profile for Trasylol (aprotinin).

Bayer Australia Ltd has distributed a letter regarding this action to healthcare professionals who use Trasylol. Healthcare professionals can obtain further information from Bayer Australia Ltd on 1800 673 270. Members of the public with any concerns should consult their surgeon.

(BART: Blood Conservation Using Antifibrinolytics: A Randomised Trial in High-Risk Cardiac Surgery)