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Safety considerations when managing gastro-esophageal reflux disease in infants

Melina Simon1, Elvira Ingrid Levy1, Yvan Vandenplas1

  • 1KidZ Health Castle, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel , Brussels, Belgium.

Expert Opinion on Drug Safety
|October 29, 2020
PubMed

Insights

Non-pharmacological treatments are safe and effective for infant gastro-esophageal reflux disease (GERD). Acid-suppressive medications carry risks, while alginates offer limited efficacy with few side effects. Prokinetics are not recommended for infant GERD.

Area of Science:

  • Pediatric Gastroenterology
  • Infant Health
  • Pharmacology

Background:

  • Gastro-esophageal reflux disease (GERD) diagnosis in infants is increasing globally.
  • This trend leads to greater exposure of infants to various therapeutic interventions.
  • Focusing on the safety of these treatments is crucial for infant well-being.

Purpose of the Study:

  • To review the safety of therapeutic options for infant gastro-esophageal reflux disease (GERD).
  • To evaluate the efficacy and adverse effects of pharmacological and non-pharmacological treatments.
  • To provide expert opinion on the rational use of GERD medications in infants.

Main Methods:

  • Systematic literature search of English articles from 1990 to May 2020.
  • Databases searched include PubMed and Google Scholar.
  • Evidence synthesis focusing on treatment safety and efficacy.

Main Results:

  • Non-pharmacological treatments for infant GERD are generally effective and safe.
  • Acid-suppressive medications are associated with adverse effects, including gastro-intestinal dysbiosis.
  • Aluminum-free alginates show some efficacy with minimal adverse effects; prokinetics are not recommended due to risks.
  • Infant GERD is often non-acid related, questioning the widespread use of acid-suppressive agents.

Conclusions:

  • Pediatric trials on GERD treatments are often underpowered regarding adverse event assessment.
  • Increased global use of anti-secretory agents in infants may be unwarranted.
  • Healthcare provider education on medication risks can promote rational use; non-pharmacological approaches are safe and effective.

Keywords:
Alginateanti-acid druggastro-esophageal refluxgastro-esophageal reflux diseaseinfantnon-pharmacological treatmentnutritional managementprokineticsafety

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