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The 2004 FDA warning on antidepressant suicidality risk changed outpatient treatment patterns for young people with new-onset depression

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What impact did the 2004 Food and Drug Administration (FDA) warning regarding antidepressant suicide risk have on the treatment of young people with new onset depression in outpatient settings?


6 113 098 young people (age 2–17 years old) with new onset depression.


US i3 INNOVUS commercial insurance database of people enrolled between July 2003 and December 2006 (July 2003 to February 2004 defined as the prewarning period and March 2004 to December 2006 as the postwarning period).


Data extracted from the i3 INNOVUS database covered demographic characteristics; inpatient, outpatient and pharmacy claims (including behavioural health services) and enrolment data. New claims for young people aged 2–12 years and adolescents aged 13–17 years were included. New onset depression was defined according to International Statistical Classification of Diseases (ICD-9) codes 296.2x, 296.3x, 300.4 or 311 occurring in people with at least 180 days of enrolment before diagnosis and no antidepressant dispensing in the 90 days before diagnosis. Outcomes during prewarning period were compared with those during postwarning period. Dispensation of selective …

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  • Sources of funding National Institutes of Health and National Institute of Child Health and Human Development


  • Competing interests JAB has presented on suicide prevention in children and adolescents at a conference supported in part by Eli Lilly and Lundbeck. KJK has no conflicting interests to disclose.