Trasylol licence suspended

20 December 2007

The licence for Trasylol (aprotinin) has been suspended on the advice of the Commission on Human Medicines (CHM). Global marketing of the drug had already been suspended voluntarily by the marketing authorisation holders (Bayer plc and Nordic Pharma) due to safety concerns.

The CHM decision to suspend the licence was made on the basis of preliminary findings from a clinical trial (the BART study), which was stopped early after excess mortality was observed in the aprotinin arm compared with the tranexamic acid and aminocaproic acid arms (relative risk 1.5).

In addition, data from observational studies suggested an increased risk of mortality as well as an increased risk of cardiac, cerebrovascular and renal effects.

Trasylol is indicated for the reduction of blood loss and need for blood transfusion in coronary artery bypass graft surgery.

The CHM concluded that although aprotinin may be more effective than the comparator drugs at reducing bleeding, the risks outweigh the benefits.

Further information: Bayer 01635 563000 and/or MHRA