Aprotinin (Trasylol®): UK licences suspended
admin November 30th, 2007
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.
Source: MHRA.
This decision is based on the findings of the BART study which was terminated early due to an excess of mortality in the aprotinin arm (relative risk of 1.5 compared to tranexamic acid and animocaproic acid). Other observational data has suggested a similar risk, as well as increased risks of cardiac, cerebrovascular and renal adverse effects. The benefits of reduced bleeding produced by aprotinin are thought to be outweighed by these risks.
Bottom line: The risks attached to aprotinin appear to outweigh its benefits, as noted by previous CHM advice. The CHM advise that “aprotinin should only be used when the likely benefits outweigh any risks to individual patients.” While aprotinin continues to be availible until the suspension of the licences, clinicians should attention to this advice. After the suspension of the UK licences, limited supplies of aprotinin for treatment of individual patients under ‘Specials’ regulations will be permitted. In that case, prescribers will be prescribing an unlicensed medication and take responsibility for its use. A European review of the data should present further information in the new year.