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Off‐label antidepressant use in children and adolescents compared with young adults: extent and level of evidence
Author(s) -
Czaja Angela S.,
Valuck Robert
Publication year - 2012
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3312
Subject(s) - medicine , pharmacy , pediatrics , pharmacoepidemiology , young adult , sertraline , retrospective cohort study , cohort study , cohort , medical prescription , antidepressant , psychiatry , gerontology , family medicine , anxiety , pharmacology
Purpose To estimate the degree of, and level of evidence supporting, off‐label antidepressant (AD) prescribing for children and adolescents compared with young adults. Methods Retrospective cohort study utilizing medical and pharmacy claims data from US‐managed care plans, 1997–2009. Participants Patients aged 5–24 years, with at least one (index) AD claim during a period of continuous enrollment. Main outcome measures Drug‐diagnosis pairs, on the basis of medical claims within 30 days pre‐index or post‐index AD, were grouped as (1) Food and Drug Administration (FDA)‐approved or (2) off‐label with one of three evidence categories based on Micromedex®2.0: favorable, inconclusive or limited‐to‐none (Thomson Micromedex, Greenwood Village, CO, USA). Results Over the study period, 290 816 subjects met eligibility criteria: 17% 5–12 years old, 40% 13–18 years old, and 43% 19–24 years old. Sertraline was the most commonly prescribed index AD (19–23%). Psychiatrists more often prescribed the AD for children (31%) and adolescents (35%) versus young adults (17%). Only 28% of all subjects had a diagnosis consistent with an FDA‐approved indication within 30 days pre‐index and post‐index AD. Children less than 13 years old were less likely to have had an FDA‐approved indication (5–10%). Most off‐label prescribing had inconclusive to no evidence supporting efficacy. The lack of evidence was especially pronounced for younger children. Trends were consistent over the study period. Increasing the time period for potential indications pre‐index and post‐index AD did not result in significantly reduced off‐label rates. Conclusions Pediatric off‐label AD prescribing occurs frequently without a strong evidence base, highlighting a need to generate additional evidence to ensure safe and effective use. Copyright © 2012 John Wiley & Sons, Ltd.