Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants.
OBJECTIVE
The aim of this analysis was to delineate trends in spontaneous postmarketing reporting data with antidepressant drugs for adverse events involving suicidal behaviors in children and adolescents.


METHODS
The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) was searched for postmarketing adverse event reports of suicidal thoughts and behaviors occurring in children and adolescents treated with 10 antidepressant drugs. The search covered the period from market launch of each drug through November 2003.


RESULTS
A total of 524 reports were returned by the search. All drugs had reports, and most drugs demonstrated 15 or fewer reports annually, with the following two exceptions. We observed a peak of reporting for fluoxetine in the early 1990s, and another peak of reporting for paroxetine in recent years. Further investigation revealed that the peak in recent paroxetine reporting was accounted for by reports from consumers, whereas reporting by health professionals remained fairly constant. In contrast, the earlier peak in reports for fluoxetine was not accounted for by an increase in consumer reporting.


CONCLUSIONS
Spontaneous reporting data for suicidal events in pediatric patients treated with antidepressant drugs appears to be highly variable and subject to various influences. The most appropriate method to assess an association of antidepressant drug treatment with suicidal behaviors is examination of systematically collected data with appropriate comparison groups, such as randomized, controlled trial data.
Division of Drug Risk Evaluation, Office of Drug Safety, U.S. Food and Drug Administration, Rockville, Maryland 20993, USA. andrew.mosholder@fda.hhs.gov
Andrew D
AD
Mosholder
Carol A
CA
Pamer
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D000928:Antidepressive Agents / Q000009:adverse effects*; D002648:Child; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing / Q000639:trends; D013405:Suicide / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends
D000928:Antidepressive Agents