Sales of aprotinin (Trasylol®) temporarily suspended

The sales of aprotinin (Trasylol®) was temporarily suspended. This is due to the findings of the Canadian BART study (Blood conservation using antifribinolytics: A randomized trial in high risk cardiac Surgery patients)1 which suggested that Trasylol® was associated with an increased risk of mortality when used in high risk cardiac surgeries compared to other 2 antifibrinolytic agents in the study.

The company's suspension of sales of Trasylol® was made in consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the US Food and Drug Administration (FDA), Health Canada, and other regulatory authorities in the interest of patient safety, based on the serious nature of the outcomes suggested in the preliminary data, and the consideration that it is not possible to identify the population of patients undergoing cardiac surgery for which the benefits of Trasylol® outweigh the risks. The US FDA has stated that the findings from the interim analysis of the BART study support those from previous observational studies which also suggested increased risks for mortality when aprotinin was compared to other antifibrinolytic drugs.2,3

As a thorough evaluation of the final data of the trial by Bayer and regulatory authorities worldwide is expected to take about 8 weeks or longer, HSA has worked with Bayer on an interim arrangement to allow a restricted access route for circumstances where the individual doctor identifies that there are no therapeutic alternatives for a patient and where the benefits of the drug outweigh the risks.

Restriction on supply of aprotinin (Trasylol®)

Under this restricted access route, Bayer will be required to obtain a written undertaking from doctors to whom the company supplies the product, that the doctor will discuss the risks involved with his patients and obtain the patient's written consent before prescribing Trasylol®. In cases where the patient is incapable of giving or incompetent to give consent, then such consent should be obtained from the patient's next-of-kin.

Although the onus of deciding whether treatment with Trasylol® is warranted in any particular patient lies with the prescribing doctor, in view of the recent safety information and the suspension of the sales worldwide, HSA strongly recommends that Trasylol® be prescribed only to patients where there are absolutely no therapeutic alternatives and where the risk-versus-benefit balance of the drug has been assessed to be favourable by the patient's doctor.

Additionally, HSA recommends that patients prescribed Trasylol® be monitored closely and any serious adverse reactions suspected to be related to Trasylol® should be reported immediately to HSA's Pharmacovigilance Unit at Tel: 6866-3538 or faxed to 6478-6069.

References

1. http://www.ohri.ca/programs/clinical_epidemiology/thrombosis_group/studies/BART.asp (accessed on 6 November 2007).
2. Mangano et al. Multicenter Study of Perioperative Ischemia Research Group; and Education Foundation. The risk associated with aprotinin in cardiac surgery. Journal of Medicine. 2006; 354(4):353-65.
3. Karkouti et al. A propensity score case-control comparison of aprotinin and tranexamic high-transfusion-risk cardiac surgery. Transfusion. 2006; 46(3):327-338.

Published: 7 Nov 2007

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