The National Institute for Health and Clinical Excellence has published a summary of evidence supporting the off-label use of Pfizer's tranexamic acid (brand name Cyklokapron) to combat severe bleeding after trauma.
Significant haemorrhage and related complications are a major cause of death following severe trauma, and account for a massive 80% of deaths in the operating theatre and up to 50% of fatalities in the first 24 hour-period post injury.
Tranexamic acid, which stops unwanted bleeding by preventing the breakdown of blood clots, is approved in several indications - including for use in women with heavy menstruation or after surgery - but, in the UK, it has not been licensed to prevent significant haemorrhage following trauma.
In its first evidence summary for an unlicensed/off-label medicine, the Institute outlines evidence from a large, multinational, "high quality" study showing that a short course of the drug, given within eight hours of injury to adult patients at risk of significant bleeding, boosts the number of those surviving their injuries.
In addition, it points to health economic analysis which concluded that using tranexamic acid to prevent and treat significant haemorrhage in trauma patients has an incremental cost of just $64 international dollars per life saved.
While NICE's evidence summaries do not constitute 'formal' guidance, they are designed to ensure that clinical decisions and choices throughout the National Health Service are based on best available data on safety and efficacy.
"Up until now there has been a lack of nationally available, good quality information about using unlicensed and off-label medicines," said Professor Mark Baker, Director of the Centre for Clinical Practice at NICE.
And as well as keeping clinicians informed, it is hoped that NICE's evidence summaries will also put a stop to various factions of the health service carrying out their own analyses of the same evidence, thereby saving valuable resources.
The first batch of NICE evidence summaries for unlicensed/off-label medicines will include Modafinil tablets for decreasing MS-related fatigue, rituximab in mantle cell lymphoma and metformin tablets for polycystic ovary disease.
The Institute has appointed healthcare research company Bazian to produce the summaries, which will form the basis of the final NICE information, it said.