Spillover effects on treatment of adult depression in primary care after FDA advisory on risk of pediatric suicidality with SSRIs

Am J Psychiatry. 2007 Aug;164(8):1198-205. doi: 10.1176/appi.ajp.2007.07010007.


Objective: In 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the risk of suicidality in pediatric patients taking selective serotonin reuptake inhibitors (SSRIs) for depression, and in 2005, the agency mandated a black box warning and medication guide indicating that pediatric and adult patients may be at risk. The authors examine the effects of this pediatric policy on treatment of adult depression in the community.

Method: An adult cohort with newly diagnosed episodes of depression was created from a large national integrated claims database of managed care plans from October 1998 to September 2005 (N=475,838 unique episodes). Time-series analyses were used to compare the post-FDA advisory trends to the trends during the 5 years preceding the advisory.

Results: The rate of diagnosed depression was significantly lower after the advisory than would have been expected on the basis of the preadvisory historical trend. The average percentage of adults with new (versus recurrent) depressive episodes was 88.6% in the preadvisory period (declining at an annual rate of 1.69%), and it decreased significantly to 77.5% (declining more rapidly, at an annual rate of 7.70%). The percentage of adults with depression who did not receive an antidepressant increased from an average of 20% (declining at 0.45% annually) before the policy action to an average of 30% (increasing at an annual rate of 20.6%). The data did not show any compensatory increases in psychotherapy or prescription of atypical antipsychotics or anxiolytics.

Conclusions: The FDA advisory had a significant spillover effect into community treatment for adults with depression, despite the focus of the policy on pediatric patients.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Advisory Committees / statistics & numerical data
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Child
  • Depressive Disorder / diagnosis
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / epidemiology
  • Drug Labeling / statistics & numerical data*
  • Drug Prescriptions / statistics & numerical data
  • Health Policy / legislation & jurisprudence
  • Humans
  • Managed Care Programs / statistics & numerical data
  • Medicine / statistics & numerical data
  • Middle Aged
  • Practice Patterns, Physicians'
  • Risk Assessment / statistics & numerical data
  • Seasons
  • Selective Serotonin Reuptake Inhibitors / adverse effects*
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Specialization
  • Suicide / psychology
  • Suicide / statistics & numerical data*
  • United States / epidemiology
  • United States Food and Drug Administration / legislation & jurisprudence


  • Serotonin Uptake Inhibitors