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Safety profile of H1-antihistamines in pediatrics: an analysis based on data from VigiBase

Domenico Motola1, Monia Donati1, Chiara Biagi1

  • 1Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Pharmacoepidemiology and Drug Safety
|June 28, 2017
PubMed

Insights

H1-antihistamines are widely used in children, but this study found serious and unexpected adverse drug reactions (ADRs). Increased awareness and education are crucial for safe pediatric prescribing and early ADR detection.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Clinical Pediatrics

Background:

  • H1-antihistamines are frequently prescribed for infants and children.
  • Limited data exists on the safety profiles of these medications in pediatric populations.
  • This study investigates H1-antihistamine safety using global adverse drug reaction data.

Purpose of the Study:

  • To conduct a comparative safety analysis of H1-antihistamines in children.
  • To identify potential adverse drug reactions (ADRs) associated with H1-antihistamine use in pediatric patients.
  • To utilize the World Health Organization's VigiBase for comprehensive safety data.

Main Methods:

  • Analysis of adverse drug reaction (ADR) reports for H1-antihistamines in children (0-16 years) from VigiBase up to June 2014.
  • Codification of ADRs using Medical Dictionary for Regulatory Activities (MedDRA) terminology.
  • Calculation of reporting odds ratios (RORs) with 95% confidence intervals to assess significant associations.

Main Results:

  • The study included 8918 reports on antihistamines, covering 19503 drug-reaction pairs for 68 drugs.
  • The majority of reports involved children aged 2-12 years.
  • Significant associations were found, including levocetirizine with epilepsy (ROR 6.57) and chlorphenamine with toxic epidermal necrolysis (ROR 7.29).
  • Serious ADRs were reported in 23% of cases, with 400 fatal outcomes.

Conclusions:

  • H1-antihistamines are commonly used in pediatrics, sometimes off-label.
  • The findings indicate associations with serious and unexpected adverse drug reactions.
  • Educational interventions for clinicians and parents are recommended for informed prescribing and early ADR detection.
Abstract

Keywords:
H1-antihistaminesadverse drug reactionpediatricspharmacoepidemiologypharmacovigilance

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