off label use
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Introduction
use of a pharmaceutical agent for an indication not approved by the FDA.
Epidemiology
- 12% of prescriptions for off-label use[2]
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]
Benefit/risk
Adverse effects
- adverse events higher for off-label use FDA-approved use (19.7 vs. 12.5 per 10,000 person-months)
More general terms
References
- ↑ Committee on Drugs Off-Label Use of Drugs in Children. Pediatrics. Feb 24, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24567009 <Internet> http://pediatrics.aappublications.org/content/early/2014/02/18/peds.2013-4060.full.pdf
- ↑ 2.0 2.1 2.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26523731 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26524668 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2467779 - ↑ 3.0 3.1 Wong J et al Treatment Indications for Antidepressants Prescribed in Primary Care in Quebec, Canada, 2006-2015. JAMA. 2016;315(20):2230-2232 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27218634 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2524175
- ↑ 4.0 4.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28228380 Free PMC Article <Internet> http://www.bmj.com/content/356/bmj.j603