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.
- Over-the-counter medication
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Contributors PDB, TC, KB, EM and MVW have expertise in clinical pharmacology and/or pharmaceutical care, including drug evaluation. MVW conceived the idea for this paper. PDB analysed the SPCs and the literature and wrote the first draft of the manuscript. All authors contributed substantially to the interpretation of the data, revised the manuscript, approved the final version and are accountable for it. PDB is the guarantor of the article.
Funding This work was supported by an IWT (Innovation by Science and Technology in Flanders) grant number SB-111279 (recipient: PDB).
Competing interests PDB is the recipient of a doctoral grant for Strategic Basic Research of the Agency for Innovation by Science and Technology (IWT) in Flanders.
Provenance and peer review Not commissioned; externally peer reviewed.
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