Safety Information
Revised: 26 June 2013
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.
For media enquiries, please contact:
Luz Baguioro
Media Advisor
Ministry of Health
DDI: 04 496 2349
Mobile: 021 802 622
