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First NICE evidence summary available for off-label medicines

Article: 8034603 pillsTranexamic acid (Cyklokapron, Pfizer) for significant haemorrhage following trauma is the topic of the first evidence summary published by NICE.

NICE evidence summaries provide a summary of published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, but where there are no clinically appropriate alternatives.

The summaries, produced by NICE's Medicines and Prescribing Centre, provide information for GPs and patients to help with decision-making and to support local formularies.

While the summaries cover the efficacy, safety and cost of a drug, they do not make up formal NICE guidance.

NICE's first evidence summary on tranexamic acid, which is currently an off-label drug, covers use of the drug to stop or reduce unwanted bleeding.

Research shows that a short course of tranexamic acid given within 8 hours of injury to adult trauma patients, with or at risk of, significant bleeding increases the proportion of people who survive their injuries.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: “Up until now there has been a lack of nationally available, good quality information about using unlicensed and off-label medicines.

“This new resource from NICE, while not formal guidance, will help to ensure that the decisions of clinicians and the choices made by patients are properly informed and made on the basis of the best available evidence.

“It will also help avoid potential duplication of effort where, as happens currently, different NHS organisations undertake their own analyses of the evidence - NICE will save them the trouble by doing it once.”

Evidence summaries on melatonin for sleep disorders in children, and metformin tablets for polcystic ovary disease are currently in development.

24 October 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.