Off-label prescribing patterns of antidepressants in children and adolescents

Pharmacoepidemiol Drug Saf. 2012 Feb;21(2):137-44. doi: 10.1002/pds.2145. Epub 2011 Apr 28.


Purpose: To understand the extent of off-label prescribing among pediatrics, the study assesses the prescribing patterns of antidepressants in ambulatory settings.

Methods: A cross-sectional analysis was conducted using the National Ambulatory Medical Care Survey from 2000 to 2006. The prevalence of off-label prescribing of antidepressants was estimated, and predictive factors were evaluated.

Participants: Children and adolescents aged 6-18 years to private physicians' offices.

Main outcome measures: Prevalence of antidepressant prescriptions including FDA and non-FDA-approved indications, types of antidepressants prescribed, and factors associated with off-label prescribing.

Results: Our study population made 18 646 visits to private physicians' offices, representing about 667 million weighted visits during the study period. The mean age of the patients was 12.2 years (SD = 3.7), and majority of the visits were made by White people (73.1%). Of all visits, 3.7% (95%CI: 3.2%-4.2%) were associated with antidepressants. The most prevalent form of antidepressants prescribed were selective serotonin reuptake inhibitors (63.7%). Only 9.2% of the visits were associated with FDA-approved indications. Visits made to pediatricians (adjusted OR = 2.4; 95%CI: 1.1-5.1), family physicians, and other offices (adjusted OR = 1.9; 95%CI: 1.2-3.1) were more likely to be associated with off-label prescribing as compared with visits to a psychiatrist's office.

Conclusions: The study observed a very high prevalence of off-label antidepressant prescribing patterns among children and adolescents in US ambulatory care settings. Coordinated efforts should be placed to evaluate the potential reasons and ramifications of antidepressant off-label prescribing to guard patients' safety.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Ambulatory Care / statistics & numerical data*
  • Antidepressive Agents / therapeutic use*
  • Child
  • Cross-Sectional Studies
  • Drug Approval
  • Female
  • Health Care Surveys
  • Humans
  • Male
  • Off-Label Use / statistics & numerical data*
  • Practice Patterns, Physicians' / statistics & numerical data*
  • United States
  • United States Food and Drug Administration


  • Antidepressive Agents