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Are antihistamines effective in children? : a review of the evidence

Pauline De Bruyne (UGent) , Thierry Christiaens (UGent) , Koen Boussery (UGent) , Els Mehuys (UGent) and Myriam Van Winckel (UGent)
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Abstract
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.
Keywords
ntihistamines, Children, Over-the-counter medication, Paediatrics, PEDIATRIC CLINICAL-PHARMACOLOGY, SEASONAL ALLERGIC RHINITIS, INFANT SLEEP DISTURBANCE, RESPIRATORY DEPRESSION, TRIMEPRAZINE TARTRATE, YOUNG-CHILDREN, CYPROHEPTADINE, ALIMEMAZINE, INFECTION, URTICARIA

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Chicago
De Bruyne, Pauline, Thierry Christiaens, Koen Boussery, Els Mehuys, and Myriam Van Winckel. 2017. “Are Antihistamines Effective in Children? : a Review of the Evidence.” Archives of Disease in Childhood 102 (1): 56–60.
APA
De Bruyne, P., Christiaens, T., Boussery, K., Mehuys, E., & Van Winckel, M. (2017). Are antihistamines effective in children? : a review of the evidence. ARCHIVES OF DISEASE IN CHILDHOOD, 102(1), 56–60.
Vancouver
1.
De Bruyne P, Christiaens T, Boussery K, Mehuys E, Van Winckel M. Are antihistamines effective in children? : a review of the evidence. ARCHIVES OF DISEASE IN CHILDHOOD. 2017;102(1):56–60.
MLA
De Bruyne, Pauline, Thierry Christiaens, Koen Boussery, et al. “Are Antihistamines Effective in Children? : a Review of the Evidence.” ARCHIVES OF DISEASE IN CHILDHOOD 102.1 (2017): 56–60. Print.
@article{8501451,
  abstract     = {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.},
  author       = {De Bruyne, Pauline and Christiaens, Thierry and Boussery, Koen and Mehuys, Els and Van Winckel, Myriam},
  issn         = { 0003-9888},
  journal      = {ARCHIVES OF DISEASE IN CHILDHOOD},
  keyword      = {ntihistamines,Children,Over-the-counter medication,Paediatrics,PEDIATRIC CLINICAL-PHARMACOLOGY,SEASONAL ALLERGIC RHINITIS,INFANT SLEEP DISTURBANCE,RESPIRATORY DEPRESSION,TRIMEPRAZINE TARTRATE,YOUNG-CHILDREN,CYPROHEPTADINE,ALIMEMAZINE,INFECTION,URTICARIA},
  language     = {eng},
  number       = {1},
  pages        = {56--60},
  title        = {Are antihistamines effective in children? : a review of the evidence},
  url          = {http://dx.doi.org/10.1136/archdischild-2015-310416},
  volume       = {102},
  year         = {2017},
}

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