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

ABSTRACT

Background

The use of proton pump inhibitors (PPIs) has increased in the last 10 years in children. Data regarding their safety profile are limited. The aim of this study was to analyze data from the Italian spontaneous reporting system (SRS) database to evaluate the incidence and characteristics of PPI-related adverse drug reactions (ADRs) in children.

Research design and methods

This was an observational, retrospective study analyzing PPI-related ADR reports in children in the Italian SRS database between January 1^st, 2001, and December 31^st, 2020. ADRs were coded according to the system organ class term level. Factors associated with ADR seriousness were investigated.

Results

Seventy spontaneous reports of ADRs related to PPIs were analyzed. Esomeprazole and lansoprazole caused the highest number of ADRs equally (27% respectively), and the most frequently reported ADRs presented with gastrointestinal (24%) and/or skin manifestations (21.3%). More than a half of PPI prescriptions were off label for pediatric population. Serious ADRs were 19 (27.1%). Serious ADRs were more frequent in reports presenting PPIs combined with other drugs in comparison to reports with PPI single therapies (p = 0.03).

Conclusions

PPI-related ADRs in children are mostly not serious, and combination therapy seems to be associated with ADR seriousness.

KEYWORDS:

• Adverse drug reaction
• label
• pediatrics
• proton pump inhibitors
• seriousness

Declaration of interest

The author(s) 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.

Author contributions

V. Dipasquale, G. Cicala, F. Laganà and P. Cutroneo collected the data and organized the results. V. Dipasquale, G. Cicala and P. Cutroneo wrote the draft of the manuscript. G. Trimarchi performed the statistical analysis. E. Spina and C. Romano supervised writing of the manuscript and revised it critically for intellectual content. All authors made substantial contributions and approved the final version of the manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2021.1978975.

Additional information

Funding

This paper was not funded.