Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs.
OBJECTIVE
In October 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. This study used data from a large national pediatric cohort to examine patterns of diagnosis of depression, prescription of antidepressants, prescription of pharmacological alternatives to antidepressants, and use of psychosocial care before and after the FDA advisory was issued.


METHODS
A large pediatric cohort with newly diagnosed episodes of depression was created from a national integrated claims database of managed care plans from October 1998 to September 2005 (N=65,349). Time-series models were used to compare diagnosing and prescribing trends during the 2 years after the FDA advisory and the expected trends based on data from the 5-year period preceding the advisory.


RESULTS
From 1999 to 2004, pediatric diagnoses of depression increased from 3 to 5 per 1,000. After the FDA advisory was issued, the national rate decreased to 1999 levels, a significant deviation from the historical trend. Pediatricians and nonpediatrician primary care physicians accounted for the largest reductions in new diagnoses. Among patients with depression, the proportion receiving no antidepressant increased to three times the rate predicted by the preadvisory trend, and SSRI prescription fills were 58% lower than predicted by the trend. There was no evidence of a significant increase in use of treatment alternatives (psychotherapy, atypical antipsychotics, and anxiolytics).


CONCLUSIONS
The FDA advisory was associated with significant reductions in aggregate rates of diagnosis and treatment of pediatric depression.
Libby
Anne M
AM
University of Colorado at Denver and Health Sciences Center, School of Medicine, Nighthorse Campbell Native Health Building, PO Box 6508, Campus Box F800, Aurora, CO 80045-0508, USA. anne.libby@uchsc.edu
Brent
David A
DA
Morrato
Elaine H
EH
Orton
Heather D
HD
Allen
Richard
R
Valuck
Robert J
RJ
D026683:Advisory Committees; D015331:Cohort Studies; D003625:Data Collection; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004363:Drug Utilization; D004335:Drug and Narcotic Control; D006291:Health Policy; D006801:Humans; D008329:Managed Care Programs / Q000706:statistics & numerical data; D010372:Pediatrics / Q000706:statistics & numerical data; D010821:Physicians, Family / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000592:standards; D011570:Psychiatry / Q000706:statistics & numerical data; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D013405:Suicide / Q000523:psychology*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D000092864:Suicide Prevention
D017367:Selective Serotonin Reuptake Inhibitors