Healthy Skepticism Library item: 10972

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Libby AM, Brent DA, Morrato EH, Orton HD, Allen R, Valuck RJ.
Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs.
Am J Psychiatry 2007 Jun; 164:(6):884-91
http://ajp.psychiatryonline.org/cgi/content/full/164/6/884

Abstract:

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.

METHOD: 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.

Keywords:
Publication Types: Comparative Study Research Support, Non-U.S. Gov't MeSH Terms: Advisory Committees Cohort Studies Data Collection Depressive Disorder, Major/diagnosis Depressive Disorder, Major/drug therapy* Depressive Disorder, Major/epidemiology* Drug Utilization Drug and Narcotic Control* Health Policy Humans Managed Care Programs/statistics & numerical data Pediatrics/statistics & numerical data Physician's Practice Patterns/standards Physicians, Family/statistics & numerical data Prescriptions, Drug/statistics & numerical data Psychiatry/statistics & numerical data Serotonin Uptake Inhibitors/adverse effects* Serotonin Uptake Inhibitors/therapeutic use* Suicide/prevention & control Suicide/psychology* United States/epidemiology United States Food and Drug Administration* Substances: Serotonin Uptake Inhibitors