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Adverse reactions related to proton pump inhibitors in pediatric population: an analysis of spontaneous reporting

Valeria Dipasquale1, Giuseppe Cicala2, Francesca Laganà1

  • 1Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi," University of Messina, Messina, Italy.

Expert Opinion on Drug Safety
|September 8, 2021
PubMed

Insights

Proton pump inhibitor (PPI) use in children has risen, but safety data is limited. Studies show most PPI adverse drug reactions (ADRs) in children are not serious, though combination therapy may increase risks.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Gastroenterology

Background:

  • Increasing use of proton pump inhibitors (PPIs) in pediatric populations over the past decade.
  • Limited available data on the safety profile of PPIs in children.
  • Need for comprehensive analysis of PPI-related adverse drug reactions (ADRs) in this demographic.

Purpose of the Study:

  • To evaluate the incidence and characteristics of PPI-related ADRs in children.
  • To analyze data from the Italian spontaneous reporting system (SRS) database.
  • To identify factors associated with the seriousness of PPI-related ADRs in pediatric patients.

Main Methods:

  • Retrospective observational study of PPI-related ADR reports in the Italian SRS database (2001-2020).
  • ADRs were coded using system organ class terminology.
  • Investigation of factors linked to ADR seriousness, including co-therapies.

Main Results:

  • Analysis of 70 spontaneous reports of PPI-related ADRs in children.
  • Esomeprazole and lansoprazole were equally implicated in 27% of ADRs.
  • Most frequent ADRs involved gastrointestinal (24%) and skin (21.3%) manifestations.
  • Over half of PPI prescriptions were off-label.
  • Serious ADRs accounted for 27.1% of reports.
  • Combination therapy with PPIs was associated with a higher incidence of serious ADRs (p=0.03).

Conclusions:

  • PPI-related ADRs in children are predominantly non-serious.
  • Combination therapy involving PPIs may be linked to an increased risk of serious adverse drug reactions in pediatric patients.
  • Further research is warranted to elucidate the safety of PPIs, especially in combination regimens.
Abstract

Keywords:
Adverse drug reactionlabelpediatricsproton pump inhibitorsseriousness

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