Andrew D Mosholder1, Carol A Pamer. 1. Division of Drug Risk Evaluation, Office of Drug Safety, U.S. Food and Drug Administration, Rockville, Maryland 20993, USA. andrew.mosholder@fda.hhs.gov
Abstract
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.
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.
Authors: Robert D Gibbons; Eisuke Segawa; George Karabatsos; Anup K Amatya; Dulal K Bhaumik; C Hendricks Brown; Kush Kapur; Sue M Marcus; Kwan Hur; J John Mann Journal: Stat Med Date: 2008-05-20 Impact factor: 2.373