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Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study

F Estelle R Simons1, Peter Silas, Jay M Portnoy

  • 1Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, Faculty of Medicine, The University of Manitoba, 820 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1R9.

The Journal of Allergy and Clinical Immunology
|June 6, 2003
PubMed

Insights

This study found cetirizine (an H1-antihistamine) to be safe in infants aged 6-11 months. No significant adverse events were noted compared to placebo, with a trend towards fewer issues in the cetirizine group.

Area of Science:

  • Pediatric Pharmacology
  • Allergy and Immunology
  • Clinical Trial Design

Background:

  • H1-antihistamines are commonly used for allergic disorders in children.
  • Limited prospective, randomized, controlled studies exist for young children, especially infants.
  • No prior studies have evaluated H1-antihistamines in infants using this rigorous methodology.

Purpose of the Study:

  • To evaluate the safety of cetirizine in infants aged 6-11 months.
  • To assess central nervous system and cardiac effects of cetirizine in this age group.
  • To provide the first randomized, double-blind, placebo-controlled data on H1-antihistamine use in infants.

Main Methods:

  • A prospective, randomized, parallel-group, double-blind, placebo-controlled study.
  • Infants aged 6-11 months with a history of H1-antihistamine use were enrolled.
  • Participants received either 0.25 mg/kg cetirizine or placebo orally twice daily for one week.

Main Results:

  • No differences in all-cause or treatment-related adverse events between cetirizine and placebo groups.
  • A trend towards fewer adverse events and sleep disturbances in the cetirizine group.
  • No significant QT interval prolongation observed in infants treated with cetirizine.

Conclusions:

  • Cetirizine demonstrated safety in this short-term study involving infants.
  • This is the first randomized, double-blind, placebo-controlled trial of an H1-antihistamine in infants.
  • Further long-term studies are recommended for cetirizine and other H1-antihistamines in this population.
Abstract

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