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J Child Adolesc Psychopharmacol. 2006 Feb-Apr;16(1-2):159-69.

Treatment-emergent adverse events from selective serotonin reuptake inhibitors by age group: children versus adolescents.

Author information

  • 1Johns Hopkins University School of Medicine, Baltimore, Maryland 21218, USA. dsafer@jhmi.edu

Abstract

OBJECTIVE:

The aim of this study was to report the frequency of common treatment-emergent adverse events (AEs) from selective serotonin reuptake inhibitors (SSRIs) in children, adolescents, and adults.

METHOD:

AE data were obtained from all published double-blind, placebo-controlled SSRI studies of children and adolescents that separated AE findings by age group. The AE findings were pooled for purposes of age-group comparisons. Double-blind, placebo-controlled SSRI studies of adolescents (n = 2) and of adults identified in systematically identified trials (n = 22) were assessed to compare patterns and rates across the age span. Other reports, primarily from the published SSRI literature, were added to clarify the findings presented.

RESULTS:

Activation and vomiting SSRI AEs were 2- to 3-fold more prevalent in children than in adolescents, and their rate was lowest in adults. Somnolence as a SSRI AE was uncommon in children; its rate increased with advancing age. Insomnia and nausea were common SSRI AEs across the age span. Activation AEs were a frequent reason for discontinuation from SSRI clinical trials in preadolescents, whereas somnolence, nausea, and insomnia AEs were the most common reasons for trial discontinuations in adults.

CONCLUSIONS:

Children are particularly vulnerable to specific AEs from certain medications, such as SSRIs. It is likely that the level of children's biological immaturity explains part of this phenomenon.

PMID:
16553536
[PubMed - indexed for MEDLINE]
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