Related Experiment Video
Updated: Mar 19, 2026
Acupoint Catgut Embedding Therapy in Traditional Chinese Medicine for Managing Allergic Rhinitis
Published on: December 20, 2024
Are antihistamines effective in children? A review of the evidence
Pauline De Bruyne1, Thierry Christiaens2,3, Koen Boussery4
1Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Insights
Many approved uses for first-generation H1-antihistamines in children lack supporting evidence. This review highlights variability in pediatric drug indications across Europe, emphasizing the need for better safety and efficacy data.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Drug Safety
Background:
- On-label prescribing, in addition to off-label use, can lead to adverse health events in children.
- First-generation H1-antihistamines are frequently prescribed to pediatric populations.
- Regulatory variations exist in drug indications and licensing across different countries.
Purpose of the Study:
- To investigate the licensed indications for first-generation H1-antihistamines in pediatric populations across Europe.
- To assess the evidence base supporting these licensed indications.
- To review reported adverse drug reactions associated with these medications.
Main Methods:
- A comprehensive review of the Summary of Product Characteristics for first-generation H1-antihistamines was conducted.
- The focus was on pediatric use and licensed indications in five European countries.
- Information on licensed indications was compared against available scientific literature and clinical trial data.
Main Results:
- Significant variability was observed in the licensed indications and age restrictions for these antihistamines among European countries.
- The majority of licensed pediatric indications are not supported by robust clinical trials evaluating efficacy and safety.
- Data on adverse drug reactions in children for these indications were also reviewed.
Conclusions:
- A substantial number of licensed indications for first-generation H1-antihistamines in pediatric patients lack an evidence-based foundation.
- This highlights potential risks associated with current prescribing practices.
- Further research and regulatory harmonization are needed to ensure the safe and effective use of these drugs in children.
Background And Aims:
During the last decades, much attention has been paid to off-label and unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, the case of first-generation H1-antihistamines is investigated, notably the range of indications for which products are licensed in different European countries and the evidence base (or lack thereof) for each indication, as well as reported adverse drug reactions.
Methods:
Review of the Summary of Product Characteristics of first-generation H1-antihistamines with a focus on paediatric use. This is plotted against the evidence available in the literature.
Results:
This investigation shows a large variability in labelled indications and licensing ages when compared in five different European countries. Moreover, most of the indications are not based on clinical trials evaluating efficacy and safety of these drugs in children.
Conclusions:
Many of the licensed indications of first-generation antihistamines do not appear to be evidence based.
Related Concept Videos
01:15Upper Respiratory Drugs: First and Second-Generation Antihistamines
Histamine binds to specific receptor sites, known as H1 receptors, on tissue cells, triggering inflammation and swelling. Antihistamines combat these effects by competing with histamine for these receptor sites. By...
01:25Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:28Acid Suppressive Drugs for Peptic Ulcer Disease: Histamine H2-Receptor Antagonists
01:16Drugs Used in Upper Respiratory Disorders: Overview
Antihistamines (e.g., Benadryl) block histamines from binding. Histamines are chemicals released during an allergic reaction in the body. As a...
01:23Upper Respiratory Drugs: Antitussives, Expectorants, and Mucolytics
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla. Benzonatate operates peripherally within the respiratory tract by...