Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents

Shauna Reinblatt, Susan Dosreis, John T. Walkup, Mark A Riddle

Research output: Contribution to journalArticle

Abstract

Objective: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels. Methods: Data from the Research Units on Pediatric Psychopharmacology (RUPP) Anxiety Study were examined for 45 youths (22 active fluvoxamine, 23 placebo) treated for Diagnostic and Statistical Manual for Mental Disorders, 4 th edition (DSM-IV) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule. As part of the double-blind placebo-controlled trial, AC-AEs were recorded by clinicians at weekly patient visits. AC-AEs were defined as hyperactivity, activation, and disinhibition. Demographic characteristics, daily doses, and week-8 blood levels were examined in relation to the presence of AC-AEs. The prevalence of AC-AE and time to first event were established for those who experienced this side effect. Results: AC-AEs were found in 10 of 22 participants (45%) receiving fluvoxamine and only 1 of 23 in the placebo group (4%). The onset of AC-AEs occurred from week 1 to week 8, with the majority occurring at or before week 4. The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs (n=16, t=-2.61, p=0.04). Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE. Conclusions: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.

Original languageEnglish (US)
Pages (from-to)119-126
Number of pages8
JournalJournal of Child and Adolescent Psychopharmacology
Volume19
Issue number2
DOIs
StatePublished - Apr 1 2009

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Fluvoxamine
Serotonin Uptake Inhibitors
Placebos
Anxiety Disorders
Diagnostic and Statistical Manual of Mental Disorders
Anxiety
Psychopharmacology
Bipolar Disorder
Appointments and Schedules
Demography
Pediatrics
Therapeutics
Research

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health

Cite this

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title = "Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents",
abstract = "Objective: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels. Methods: Data from the Research Units on Pediatric Psychopharmacology (RUPP) Anxiety Study were examined for 45 youths (22 active fluvoxamine, 23 placebo) treated for Diagnostic and Statistical Manual for Mental Disorders, 4 th edition (DSM-IV) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule. As part of the double-blind placebo-controlled trial, AC-AEs were recorded by clinicians at weekly patient visits. AC-AEs were defined as hyperactivity, activation, and disinhibition. Demographic characteristics, daily doses, and week-8 blood levels were examined in relation to the presence of AC-AEs. The prevalence of AC-AE and time to first event were established for those who experienced this side effect. Results: AC-AEs were found in 10 of 22 participants (45{\%}) receiving fluvoxamine and only 1 of 23 in the placebo group (4{\%}). The onset of AC-AEs occurred from week 1 to week 8, with the majority occurring at or before week 4. The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs (n=16, t=-2.61, p=0.04). Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE. Conclusions: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.",
author = "Shauna Reinblatt and Susan Dosreis and Walkup, {John T.} and Riddle, {Mark A}",
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