Revised: 26 June 2013

Safety Information

Aprotinin - Increased caution is warranted

26 October 2007

Advice from Medsafe

The following advice was circulated by e-mail to anaesthetists, cardiothoracic and other surgeons, haematologists, and transfusion specialists.

• Medsafe is aware that the US FDA has issued an early communication to advise that the BART study (Blood conservation using Antifibrinolytics: a Randomised Trial in a cardiac surgery population) has been halted by the study investigators because preliminary findings suggest that, compared to tranexamic acid and aminocaproic acid, aprotinin increases the risk of death.
• The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding associated with cardiac surgery; and to examine outcomes and risk profiles of these medicines. The study had planned to enroll approximately 3,000 adult Canadian patients who were to undergo various types of cardiac surgery that placed them at high risk for bleeding.
• In New Zealand, the safety of aprotinin has been under review by Medsafe and the Medicines Adverse Reactions Committee (MARC) since March 2006. The Trasylol prescribing information was updated in April 2006 and again in November 2006 to limit the approved indications to those patients at high risk of blood loss or transfusion. These changes were consistent with those occurring in other countries and were implemented to help improve the benefit-risk profile of aprotinin.
• Aprotinin was most recently discussed at the March 2007 MARC meeting, where the Committee recommended that aprotinin continue to monitored by both Medsafe and the MARC, including considering the results of the BART study when these became available.
• The BART study has further increased local and international interest in the safety of aprotinin and increased caution is warranted with this medicine.
• The US FDA will be re-evaluating the overall risks and benefits of aprotinin before making a decision about the safety and ongoing use of this medicine.
• Medsafe will continue to closely monitor the issue, in conjunction with NZ clinicians. Medsafe will also liaise with other regulators and review new information as it becomes available.
• In the interim, Medsafe recommends that clinicians consider each patient on an individual basis to determine whether aprotinin is appropriate for that patient, taking into account the accumulating data suggesting aprotinin increases the risk for death compared to other antifibrinolytic drugs. In some patients, other medicines such as tranexamic acid should be considered as an alternative option.
• Medsafe will inform clinicians of any further developments.

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