MHRA response to the termination of the BART Study on the use of aprotinin (Trasylol)

29 October 2007

Aprotinin (Trasylol) is indicated for the prevention of major blood loss during coronary artery bypass graft surgery. Since 2006, the safety of aprotinin has been kept under review within Europe due to emerging evidence of adverse effects on the kidney as well as a possible increased risk of heart and cerebral disorders and death. On the basis of the evidence of kidney dysfunction, action was taken within Europe last year to restrict the usage of aprotinin only as a preventative to reduce blood loss in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk of blood loss or blood transfusion. The letter sent by Bayer HealthCare in September 2006 to healthcare professionals informing them of new prescribing advice was published on the MHRA website:
› Trasylol (aprotinin injection): New prescribing advice: restricted indication and risk of renal dysfunction

As the evidence of an increased risk of death and heart and cerebral disorders was inconclusive, no further action was taken until more data are available.

The MHRA learned last week that a clinical trial (the BART Study) being conducted in North America has been stopped early due to a possible excess number of deaths in patients being treated with aprotinin compared to patients treated with the alternative drugs, epsilon aminocaproic acid or tranexamic acid. This was despite evidence from the trial that aprotinin was associated with less serious bleeding (including bleeding severe enough to require re-operation) than the other two drugs. This trial was conducted by independent researchers and little further information from this study is currently available.

We are in the process of gathering more information about these findings so that a proper assessment of the balance of risks and benefits of aprotinin can be made and further regulatory can be taken if justified by the data. In the meantime, prescribers are reminded of the current restrictions and warnings in relation to the use of aprotinin available in the product information and on the electronic Medicines Compendium website (external link)