Impact of the 2004 Food and Drug Administration Pediatric Suicidality Warning on Antidepressant and Psychotherapy Treatment for New-Onset Depression

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Objective:To assess the national impact of the March 2004 Food and Drug Administration (FDA) antidepressant suicidality warning on the outpatient treatment of new-onset depression in youth.Method:A repeated measures, longitudinal design in a cohort of youth diagnosed with new-onset depression was used to assess pre- and post-FDA warning effects. US commercial insurance enrollees in the i3 INNOVUS database from January 2003 through December 2006 were examined. The study population included youth 2- to 17-years old with a new-onset depression diagnosis from July 2003 through June 2006 (N = 40,309). The main independent variables were the warning period (post- vs. pre-FDA warning) and age group (children vs. adolescents). The main outcome measures were youth with antidepressant dispensings and psychotherapy visits measured in 30-day intervals across 36 months following a new-onset diagnosis of any depressive disorder (N = 40,309) and specifically major depressive disorder (MDD) (N = 11,532).Results:Compared to youth with a new-onset diagnosis of depression in the pre-FDA warning period, youth with new-onset diagnosis of depression during the postwarning period had (1) A significantly lower likelihood of antidepressant use: (odds ratio [OR] = 0.85 [0.81–0.89]); When youth with the diagnosis of depression were separated into those with MDD and those with less severe depression diagnoses, only the latter had a significant postwarning antidepressant decline. (2) A significant increase in the odds of a psychotherapy visit (children, OR = 1.31 [1.23–1.40]; adolescents OR = 1.19 [1.15–1.24]).Conclusions:The FDA suicidality warning was associated with an overall decrease in antidepressant treatment for youth with a clinician-reported diagnosis of depression, but not for those with MDD. Also, following the warning, psychotherapy without medication increased.

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