Regulatory Focus™ > News Articles > Pfizer's Cyklokapron Green Lighted for Off-Label Use by NHS

Pfizer's Cyklokapron Green Lighted for Off-Label Use by NHS

Posted 22 October 2012 | By Louise Zornoza

The UK's cost containment agency, the National Institute for health and Clinical Excellence (NICE), has published supporting evidence for the off-label use of Pfizer's Cyklokapronby the National Health Service (NHS) for significant severe bleeding following trauma.  

The publication is the first edition of what NICE calls the Evidence Summary, which summarizes the published evidence for the off-label use of medicines for indications for which there are no clinically appropriate licensed alternatives.  According to Professor Mark Baker, the Director of NICE's Center for Clinical Practice, "[S]ituations will arise where the use of unlicensed medicines or the use of medicines to treat conditions for which they are not licensed may be judged by the prescriber to be in the best interest of the patient."

Significant hemorrhage and its complications are a considerable cause of death following severe trauma and are responsible for 80% of deaths in the operating theater and up to 50% of deaths in the first 24 hours after injury. 

Tranexamic acid is a drug used to stop or reduce unwanted bleeding by stopping blood clots from breaking down, allowing the clots to stop the bleeding. It is licensed in Europe and the UK for use in certain conditions, for example after surgery, or in women with heavy menstrual bleeding. However, it does not currently have UK marketing authorization for use after trauma, so use in this way is described as 'off-label'. 

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