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Are antihistamines effective in children? A review of the evidence
  1. Pauline De Bruyne1,
  2. Thierry Christiaens2,3,
  3. Koen Boussery4,
  4. Els Mehuys4,
  5. Myriam Van Winckel1
  1. 1Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
  2. 2Department of Family Medicine and Primary Health Care, Ghent University, Ghent, Belgium
  3. 3Faculty of Medicine and Health Sciences, Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
  4. 4Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium
  1. Correspondence to Pauline De Bruyne, Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University Hospital, 3K12D, De Pintelaan 185, Ghent 9000, Belgium; pauline.debruyne{at}


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.

  • Paediatrics
  • Children
  • Antihistamines
  • Over-the-counter medication

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