The Pharmaceutical Journal
Vol 279 No 7481 p641
8 December 2007

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Aprotinin licence suspended

Aprotinin (Trasylol) is no longer routinely available in the UK after the Medicines and Healthcare products Regulatory Agency officially suspended its marketing authorisation pending the outcome of a full Europe-wide review of its safety. This is expected to take at least three months.

Bayer and Nordic Pharma temporarily suspended global marketing of the drug earlier this month (PJ, 10 November 2007, p519) after a clinical trial revealed excess mortality in the aprotinin arm (relative risk 1.5 compared with both tranexamic acid and aminocaproic acid).

The Commission on Human Medicines has advised that the licence be suspended from 7 December 2007 until further notice. It was unable to simply restrict use within the current licence since specific patient groups who may be at increased risk of mortality, or who may gain most benefit from aprotinin, cannot be identified from current data.

A limited supply of aprotinin will remain available for use on a named patient basis under “specials” regulations.