Aprotinin (Trasylol): Suspension of UK marketing authorisations (licences)

29 November 2007

We informed you on 6 November that the marketing authorisation holders for aprotinin (Trasylol), Bayer and Nordic Pharma, had voluntarily suspended global marketing of the drug due to concerns over safety:
› Trasylol (aprotinin) - worldwide suspension of marketing pending full review of risks and benefits

The Commission on Human Medicines (CHM) has now advised that the UK marketing authorisations (licences) should be suspended pending the outcome of a full Europe-wide review of the balance of risks and benefits of aprotinin . This review is expected to take at least three months and the licences will be suspended from 7 December until further notice.

The Commission’s advice to suspend the licences was based on the preliminary findings from a triple-blind, triple-dummy randomised clinical trial (the BART study) which was recently terminated due to an excess of mortality in the aprotinin arm (relative risk of 1.5 compared to both tranexamic acid and aminocaproic acid). The decision was supported by evidence from recent observational studies which suggest a similar risk as well as increased risks of cardiac, cerebrovascular and renal adverse effects. The Commission noted that aprotinin may be more beneficial than the comparator drugs in reducing bleeding, but considered that this benefit was outweighed by these risks. The Commission was also concerned that specific patient groups who may be at increased of mortality, or who may gain most benefit from aprotinin, cannot be identified based on current data. It was therefore not possible to further restrict use within the licence to ensure patient safety.

At present, there is no formal recall of the drug in the UK. Until the licences are suspended, there is opportunity for re-supply of aprotinin. Prescribers are reminded of the advice in our statement of 6 November that aprotinin should only be used when the likely benefits outweigh any risks to individual patients. We ask you to give very careful consideration to the available evidence on the possible risks of aprotinin in deciding whether aprotinin is suitable for your patients. Following the suspension, limited supply of aprotinin to individual patients under ‘Specials’ regulations will be permitted. Prescribers are reminded that any such use would be unlicensed and that the responsibility for use rests with them.

The MHRA will issue further guidance when the European review is completed.

Please continue to report any suspected adverse reactions via the Yellow Card Scheme:
› Reporting suspected adverse drug reactions