Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs

Am J Psychiatry. 2008 Jan;165(1):42-50. doi: 10.1176/appi.ajp.2007.07010205. Epub 2007 Nov 6.


Objective: The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued.

Method: Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures.

Results: Less than 5% of all patients met FDA contact recommendations before the advisory, and the rate did not change after the advisory. A greater proportion of patients met the HEDIS contact criterion before the advisory (60% for children and 40% for adults), and the rate did not change after the advisory. A greater proportion of pediatric patients seen by a psychiatrist (80%) met the HEDIS criterion than those seen by a pediatrician (60%) or a non-pediatrician primary care physician (54%), and than adults seen by a psychiatrist (65%) or a primary care physician (37%). The proportions of pediatric patients who met the FDA recommendations did not differ by specialty.

Conclusions: Contrary to expectations, the frequency of visits by patients with new episodes of depression treated with antidepressants did not increase after the October 2003 FDA advisory was issued.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Advisory Committees / legislation & jurisprudence
  • Age Factors
  • Antidepressive Agents, Second-Generation / adverse effects*
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Appointments and Schedules
  • Child
  • Child, Preschool
  • Cohort Studies
  • Drug Labeling / legislation & jurisprudence
  • Drug Monitoring
  • Follow-Up Studies
  • Humans
  • Legislation, Medical
  • Medicine / statistics & numerical data
  • Office Visits / statistics & numerical data*
  • Physician-Patient Relations*
  • Practice Patterns, Physicians' / legislation & jurisprudence*
  • Risk Factors
  • Serotonin Uptake Inhibitors / adverse effects*
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Specialization
  • Suicide / prevention & control*
  • Suicide / statistics & numerical data
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence


  • Antidepressive Agents, Second-Generation
  • Serotonin Uptake Inhibitors