Intended for healthcare professionals


Off-label prescribing of antidepressants

BMJ 2017; 356 doi: (Published 21 February 2017) Cite this as: BMJ 2017;356:j849
  1. Daniel R Morales, general practitioner and discovery fellow,
  2. Bruce Guthrie, professor of primary care medicine
  1. Population Health Sciences Division, University of Dundee Medical School, Dundee DD2 4BF, UK
  1. Correspondence to: B Guthrie b.guthrie{at}

Strength of evidence matters more than presence or absence of a specific licence

In most countries, medicines have a product licence that describes how they should be used. Licensing is intended to ensure that medicines meet acceptable standards of efficacy, safety, and quality for a particular indication in a particular group of patients.1 “Off-label” use occurs when a drug is prescribed for an unlicensed indication, to an unlicensed patient group (such as children), and/or as an unlicensed dosage or formulation. In their paper (doi:10.1136/bmj.j603), Wong and colleagues found that almost a third of antidepressants were prescribed for off-label indications, most commonly pain, insomnia, and migraine.2

Clinicians can legally prescribe off-label, and professional licensing agencies recognise that off-label use is necessary if licensed medicines are ineffective, if they are associated with adverse effects, or if the licensed dose or formulation does not meet the patient’s needs. Professional responsibility in these circumstances is fundamentally the same as for on-label prescribing. As the UK medical regulator says, “We …

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