Safety considerations when managing gastro-esophageal reflux disease in infants

ABSTRACT

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 nonacid 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.

KEYWORDS:

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

Article highlights

• Gastro-esophageal reflux (disease) is frequent in infants, and is associated with distress and decreased quality of life.

• Nutritional management is effective and devoid of serious adverse effects. There is limited evidence regarding some specific probiotic strains.

• There is lack of evidence of benefit for prokinetic medications, and all are associated with adverse effects.

• Acid-blocking medications do not treat reflux but change acid to non-acid reflux and are associated with dysbiosis, what may have a negative impact on immune development in infants.

• There is limited evidence that aluminum-free antacids may be of benefit; these are likely to be devoid of severe adverse effects.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.