Trasylol licence suspended

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

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases