作者: Pauline De Bruyne , Thierry Christiaens , Koen Boussery , Els Mehuys , Myriam Van Winckel
DOI: 10.1136/ARCHDISCHILD-2015-310416
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摘要: Background and aims During the last decades, much attention has been paid to off-label unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, case of first-generation H 1 -antihistamines is investigated, notably range indications for which products are licensed different European countries evidence base (or lack thereof) each indication, as well reported adverse drug reactions. Methods Review Summary Product Characteristics with a focus on paediatric use. This plotted against available literature. Results investigation shows large variability labelled licensing ages when compared five countries. Moreover, most not based clinical trials evaluating efficacy safety these drugs children. Conclusions Many antihistamines do appear be based.