Persisting decline in depression treatment after FDA warnings

Arch Gen Psychiatry. 2009 Jun;66(6):633-9. doi: 10.1001/archgenpsychiatry.2009.46.


Context: In October 2003 the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidality for pediatric patients taking antidepressants; a boxed warning, package insert, and medication guide were implemented in February 2005. The warning was extended to young adults aged 18 to 24 years in May 2007. Immediately following the 2003 advisory, unintended declines in case finding and non-selective serotonin reuptake inhibitor substitute treatment were shown for pediatric patients, and spillover effects were seen in adult patients, who were not targeted by the warnings.

Objective: To determine whether the unintended declines in depression care persisted for pediatric, young adult, and adult patients.

Design: Time series analyses.

Setting: Ambulatory care settings nationally. Patients Pediatric, young adult, and adult cohorts of patients with new episodes of depression (n = 91 748, 70 311, and 630 748 episodes, respectively).

Interventions: Post-FDA advisory trends were compared with expected trends based on preadvisory patterns using a national integrated managed care claims database from July 1999 through June 2007.

Main outcome measures: Depression diagnosis; antidepressant, antipsychotic, and anxiolytic prescriptions; and psychotherapy visits.

Results: Changes in pediatric depression care were similar to changes for adults. National diagnosis rates of depression returned to 1999 levels for pediatric patients and below 2004 levels for adults. Primary care providers continued significant reductions in new diagnoses of depression (44% lower for pediatric, 37% lower for young adults, 29% for adults); diagnoses by mental health providers who were not psychiatrists increased. Numbers of prescriptions of anxiolytic and atypical antipsychotic medications did not significantly change from preadvisory trends. Psychotherapy increased significantly for adult, though not pediatric, cases. Selective serotonin reuptake inhibitor use decreased in all cohorts; serotonin-norepinephrine reuptake inhibitor increased for adults.

Conclusions: Diagnosing decreases persist. Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued, suggesting that unintended effects are nontransitory, substantial, and diffuse in a large national population. Policy actions are required to counter the unintended consequences of reduced depression treatment.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antidepressive Agents / adverse effects*
  • Antidepressive Agents / therapeutic use
  • Child
  • Child, Preschool
  • Cohort Studies
  • Cross-Sectional Studies
  • Depressive Disorder, Major / diagnosis
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / epidemiology
  • Drug Utilization Review / statistics & numerical data
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Prescriptions / statistics & numerical data*
  • Serotonin Uptake Inhibitors / adverse effects*
  • Serotonin Uptake Inhibitors / therapeutic use
  • Suicide / prevention & control*
  • United States
  • United States Food and Drug Administration*
  • Young Adult


  • Antidepressive Agents
  • Serotonin Uptake Inhibitors