Evidence summaries: unlicensed/off-label medicines

'Evidence summaries: unlicensed/off-label medicines' summarise the best available evidence for selected unlicensed and off-label medicines.

Unlicensed and off-label medicines have a valuable role in the care of certain patients when there are no suitable licensed medicines available which meet their needs. However, information for healthcare professionals and patients to decide whether these medicines are safe and effective, and when they are most likely to yield good patient outcomes, can be difficult to find. It is estimated that around 1,000 specific requests for off-label drug use are made to NHS commissioners in England every year.

The summaries are the first nationally-available source of information for healthcare professionals and patients. They allow evidence-based prioritisation, treatment and funding decisions to be made where there are no clinically-appropriate licensed alternatives.

The strengths and weaknesses of the relevant evidence are critically reviewed, but the summaries do not constitute formal NICE guidance.

Our integrated process statement sets out how we select topics and prepare the summaries.

Published Evidence summaries: unlicensed/off-label medicines

Title Date published
ESUOM1 Significant haemorrhage following trauma: tranexamic acid 16 October 2012
ESUOM2 Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin 04 January 2013
ESUOM3 Chronic anal fissure: 2% topical diltiazem hydrochloride 22 January 2013
ESUOM4 Preventing recurrent hypomagnesaemia: oral magnesium glycerophosphate 29 January 2013
ESUOM5 Postural hypotension in adults: midodrine 5 February 2013
ESUOM6 Polycystic ovary syndrome: metformin in women not planning pregnancy 26 February 2013
ESUOM7 Chronic anal fissure: 0.2% topical glyceryl trinitrate ointment 26 March 2013
ESUOM8 Attention deficit hyperactivity disorder in children and young people: clonidine 02 April 2013
ESUOM9 Fatigue in multiple sclerosis: modafinil 02 April 2013
ESUOM10 Nocturia and nocturnal polyuria in men with lower urinary tract symptoms: oral desmopressin 09 April 2013
ESUOM11 Induction of labour in late intrauterine fetal death: vaginal misoprostol (after oral mifepristone) 30 April 2013
ESUOM12 Generalised anxiety disorder: quetiapine 15 May 2013
ESUOM13 Gastroparesis in adults: oral erythromycin 18 June 2013
ESUOM14 Chronic anal fissure: botulinum toxin type A injection 25 June 2013
ESUOM15 Hypersalivation: oral glycopyrronium bromide 02 July 2013
ESUOM16 Hyperhidrosis: oral glycopyrronium bromide 09 July 2013
ESUOM17 Multidrug resistant urinary tract infections: fosfomycin trometamol 23 July 2013
ESUOM18 Promoting tolerance of enteral feeds in children and young people: domperidone 30 July 2013
ESUOM19 Schizophrenia: omega-3 fatty acid medicines 24 September 2013
ESUOM20 Postural hypotension in adults: fludrocortisone 22 October 2013
ESUOM21 Ovarian cancer (advanced): bevacizumab 7.5 mg/kg in combination with paclitaxel and carboplatin for first-line treatment 22 October 2013
ESUOM22 Bile acid malabsorption: colesevelam 29 October 2013
ESUOM23 Transient ischaemic attack: clopidogrel 13 December 2013
ESUOM24 Critical limb ischaemia in peripheral vascular disease: intravenous iloprost 17 December 2013
ESUOM25 Non-cystic fibrosis bronchiectasis: colistimethate sodium 06 January 2014
ESUOM26 Interstitial cystitis: dimethyl sulfoxide bladder instillation 20 February 2014
ESUOM27 Chronic pain: oral ketamine 25 February 2014
ESUOM28 Rapid tranquillisation in mental health settings: promethazine hydrochloride 11 March 2014
ESUOM29 Difficult-to-treat scabies: oral ivermectin 18 March 2014
ESUOM30 Pouchitis: rifaximin 25 March 2014

Evidence summaries unlicensed/off-label medicines: coming soon

Title Expected date of publication
Certirizine: High dose use in urticaria (when licensed doses of antihistamines are ineffective) July 2014
Mycophenolate: Systemic lupus erythematosus July 2014
Mycophenolate: Scleroderma July 2014
Flunarizine (second line option for prevention): Migraine August 2014

This page was last updated: 21 March 2014

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Selected, reliable information for health and social care in one place

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.