Safety considerations when managing gastro-esophageal reflux disease in infants

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6 Citations (Scopus)


INTRODUCTION: Gastro-esophageal reflux disease (GERD) in infants is worldwide diagnosed with increasing frequency, resulting in an increasing number of infants exposed to treatment. In this review, we focus on the safety of therapeutic options.

AREAS COVERED: English articles were searched from 1990 until May 2020 in PubMed and Google Scholar. Evidence suggests that non-pharmacological treatment is often effective and safe. Guidelines restrict pharmacological treatment to acid-suppressive medication, which is associated with adverse effects, often related to gastro-intestinal dysbiosis and consequences of the latter. Aluminum-free alginates have some efficacy and are not associated with relevant adverse effects. Especially in infants, GERD is often non-acid related. Prokinetics are not recommended because of lack of efficacy and numerous adverse effects.

EXPERT OPINION: Pediatric trials are underpowered regarding adverse effects. The number of infants exposed to anti-secretory agents is increasing worldwide, often without indication. Informing healthcare providers about adverse effects of acid-secretory medication may contribute to a more rational use. Acid inhibiting agents such as alginates are a drug class associated with limited efficacy and devoid of serious adverse effects. Regarding prokinetics, the risk of adverse effects outweighs the benefit. Reassurance of parents and nutritional management of GERD in infants is effective and safe.

Original languageEnglish
Pages (from-to)37-49
Number of pages13
JournalExpert Opinion on Drug Safety
Issue number1
Early online date2020
Publication statusPublished - Jan 2021

Bibliographical note

Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.

Copyright 2021 Elsevier B.V., All rights reserved.


  • alginate
  • anti-acid drug
  • gastro-esophageal reflux
  • gastro-esophageal reflux disease
  • infant
  • non-pharmacological treatment
  • nutritional management
  • prokinetic
  • safety


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