The UK licence for Bayer AG's blood-loss agent Trasylol has been suspended on the advice of the Commission on Human Medicines, pending the results of a European review on the drug’s benefit-risk ratio.

Earlier this month, Bayer temporarily suspended sales of Trasylol (aprotinin) after preliminary findings from a study in Canada indicated a higher risk of death compared to two antifibrinolytic drugs - epsilon-aminocaproic acid and tranexamic acid - used in the trial.

According to the Medicines and Healthcare products Regulatory Agency, the Commission’s decision was based on these preliminary findings, and “supported by evidence from recent observational studies, which suggest a similar risk as well as increased risks of cardiac, cerebrovascular and renal adverse effects”.

Explaining the Commission’s decision, the MHRA said that, as specific patient groups who may be at increased risk of mortality, or indeed those likely to gain the most from treatment with the drug, cannot be identified on current data, it could not recommend any restrictions on the use of Trasylol, and so advised the suspension of its marketing license instead to ensure patient safety.

Benefit/risk ratio in question
The move also follows a call by the European Medicines Agency’s Committee for Medicinal Products for Human Use to suspend marketing authorisations for Trasylol throughout Europe, as benefits “no longer outweigh their risks”.

The UK licence for the drug will be suspended as of December 7, the MHRA said, and confirmed that a final decision will be made once the results of a European-wide review on the safety of the drug - which is expected to take at least three months - become available.

A spokesperson from Bayer was not available for comment before going to press.