title: Impact of the 2004 Food and Drug Administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
authors.forename: Satish
authors.initials: S
authors.lastname: Valluri
authors.forename: Julie M
authors.initials: JM
authors.lastname: Zito
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Safer
authors.forename: Ilene H
authors.initials: IH
authors.lastname: Zuckerman
authors.forename: C Daniel
authors.initials: CD
authors.lastname: Mullins
authors.forename: James J
authors.initials: JJ
authors.lastname: Korelitz
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000187:drug effects; D026683:Advisory Committees; D017668:Age of Onset; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002652:Child Behavior / Q000187:drug effects; D002675:Child, Preschool; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology; D004348:Drug Labeling / Q000379:methods; D017723:Drug Utilization Review / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D016017:Odds Ratio; D010372:Pediatrics / Q000458:organization & administration; D010818:Practice Patterns, Physicians' / Q000592:standards; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012720:Severity of Illness Index; D013406:Suicide, Attempted / Q000517:prevention & control* / Q000523:psychology / Q000706:statistics & numerical data; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors