title: Are antihistamines effective in children? A review of the evidence.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
authors.forename: Pauline
authors.initials: P
authors.lastname: De Bruyne
authors.affiliation: Department of Family Medicine and Primary Health Care, Ghent University, Ghent, Belgium.|Faculty of Medicine and Health Sciences, Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Christiaens
authors.affiliation: Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: Boussery
authors.affiliation: Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.
authors.forename: Els
authors.initials: E
authors.lastname: Mehuys
authors.affiliation: Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
authors.forename: Myriam
authors.initials: M
authors.lastname: Van Winckel
mesh_terms: D002648:Child; D003533:Cyproheptadine / Q000627:therapeutic use; D004115:Dimethindene / Q000627:therapeutic use; D017277:Drug Approval; D004348:Drug Labeling; D019317:Evidence-Based Medicine; D006633:Histamine Antagonists / Q000627:therapeutic use*; D006801:Humans; D056687:Off-Label Use; D016896:Treatment Outcome; D014291:Trimeprazine / Q000627:therapeutic use
chemical_list: D006633:Histamine Antagonists; D003533:Cyproheptadine; D004115:Dimethindene; D014291:Trimeprazine
keywords: Antihistamines; Children; Over-the-counter medication; Paediatrics