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6 November 2007
The marketing authorisation holders for aprotinin (Trasylol), Bayer and Nordic Pharma, have voluntarily suspended global marketing of the drug due to concerns over safety. The UK Commission on Human Medicines will advise this week on any formal regulatory action and appropriate advice to UK prescribers. In the meantime, and as a precautionary approach, our advice is that aprotinin should only be used after careful consideration in individual cases where, for example, the risk of blood loss during surgery is considered to be particularly high (for example, redo CABG (coronary artery bypass graft surgery), where there is no suitable alternative, and only when the likely benefits outweigh any risks to individual patients.
Aprotinin is indicated for the prevention of major blood loss during coronary artery bypass graft surgery. Since 2006, the safety of aprotinin has been kept under review within Europe due to emerging evidence of adverse effects on the kidney as well as a possible increased risk of heart and cerebral disorders and death. On the basis of the evidence of kidney dysfunction, action was taken within Europe last year to restrict the usage of aprotinin only as a preventative to reduce blood loss in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk of blood loss or blood transfusion. As the evidence of an increased risk of death and heart and cerebral disorders was inconclusive, no further action was taken until more data are available.
A clinical trial being conducted in North America was recently stopped early due to a possible excess number of deaths in patients being treated with aprotinin compared to patients treated with the alternative drugs, epsilon aminocaproic acid or tranexamic acid. This was despite evidence from the trial that aprotinin was associated with less serious bleeding (including bleeding severe enough to require re-operation) than the other two drugs. This trial was conducted by independent researchers and very little further information from this study is currently available.
A full regulatory review of the balance of risks and benefits of aprotinin is underway. The outcome of this depends on availability of data from the BART study and this may take at least three months. Any further advice will be issued as soon as available.
