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off label use
use of a pharmaceutical agent for an indication not approved by the FDA.
Indications:
* 25% of antidepressant prescriptions in Canada for off-label use 2006-2015 [3]
* of the off-label uses for antidepressants, only 3 with strong evidence supporting use [4]
Epidemiology:
- 12% of prescriptions for off-label use [2]
Benefit/risk:
- NNH = 1389 within 1 month [2]
Adverse effects:
- adverse events higher for off-label use FDA-approved use (19.7 vs. 12.5 per 10,000 person-months)
General
pharmacologic therapy
References
- Committee on Drugs
Off-Label Use of Drugs in Children.
Pediatrics. Feb 24, 2014
PMID: 24567009
http://pediatrics.aappublications.org/content/early/2014/02/18/peds.2013-4060.full.pdf
- Physician's First Watch, Nov 3, 2015
David G. Fairchild, MD, MPH, Editor-in-Chief
Massachusetts Medical Society
http://www.jwatch.org
- Eguale T et al
Association of Off-Label Drug Use and Adverse Drug Events in
an Adult Population.
JAMA Intern Med. Published online November 02, 2015
PMID: 26523731
http://archinte.jamanetwork.com/article.aspx?articleid=2467782
- Good CB, Gellad WF
Off-Label Drug Use and Adverse Drug Events: Turning up the Heat
on Off-Label Prescribing.
JAMA Intern Med. Published online November 02, 2015
PMID: 26524668
http://archinte.jamanetwork.com/article.aspx?articleid=2467779
- Wong J et al
Treatment Indications for Antidepressants Prescribed in
Primary Care in Quebec, Canada, 2006-2015.
JAMA. 2016;315(20):2230-2232
PMID: 27218634
http://jama.jamanetwork.com/article.aspx?articleid=2524175
- Wong J, Motulsky A, Abrahamowicz M et al.
Off-label indications for antidepressants in primary care:
Descriptive study of prescriptions from an indication based
electronic prescribing system.
BMJ 2017;356:j603
PMID: 28228380 Free PMC Article
http://www.bmj.com/content/356/bmj.j603