Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions
<b>Background</b>: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age...
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MDPI AG
2025-05-01
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| author | Hülya Tezel Yalçın Nadir Yalçın Karel Allegaert |
| author_facet | Hülya Tezel Yalçın Nadir Yalçın Karel Allegaert |
| author_sort | Hülya Tezel Yalçın |
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| description | <b>Background</b>: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age, other PPIs are also frequently prescribed. <b>Objectives</b>: This study utilizes FDA Adverse Event Reporting System (FAERS) data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population. <b>Methods</b>: This observational cross-sectional study was conducted using an individual case safety report (ICSR) database. Only reports in neonates or infants receiving omeprazole, pantoprazole, lansoprazole, rabeprazole, or esomeprazole monotherapy were evaluated. The most frequently prescribed PPI, the most common indication, the most reported ADE, the seriousness of AEs, and the countries reporting the highest ADE number were analyzed using 2D disproportionality analyses (e.g., reporting odds ratio (RORs)). <b>Results</b>: A total of 464 patients were included; 323 (69.6%) of them were stated as serious and 15 (3.2%) of them were stated as time-related to mortality. Most of the ADEs were reported for lansoprazole (45.9%). The most reported PPI-associated ADE was vomiting (8.8%). According to the RORs analysis, vomiting associated with PPI monotherapy was more likely to occur (RORs: 2.88, 95% CI: 2.09–3.96), which is followed by diarrhea, hypertrichosis, choking, and erythema. Additionally, medication errors were reported in 50 (10.8%) patients. <b>Conclusions</b>: ICSR databases are valuable pharmacovigilance tools. The absence of access to a causality assessment is a limitation since it limits its ability to confirm whether the ADEs are truly caused by the suspected drug, mitigated using RORs analysis. Integrating neonatal-specific algorithms could enhance drug safety evaluations, strengthen evidence-based decision-making, and improve risk–benefit assessments in neonates and infants. |
| format | Article |
| id | doaj-art-b0f9460404bf402baa9efc91d76faa21 |
| institution | OA Journals |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-b0f9460404bf402baa9efc91d76faa212025-08-20T02:33:47ZengMDPI AGPharmaceuticals1424-82472025-05-0118573010.3390/ph18050730Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key DecisionsHülya Tezel Yalçın0Nadir Yalçın1Karel Allegaert2Department of Pharmaceutical Toxicology, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, TürkiyeDepartment of Clinical Pharmacy, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, TürkiyeClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium<b>Background</b>: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age, other PPIs are also frequently prescribed. <b>Objectives</b>: This study utilizes FDA Adverse Event Reporting System (FAERS) data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population. <b>Methods</b>: This observational cross-sectional study was conducted using an individual case safety report (ICSR) database. Only reports in neonates or infants receiving omeprazole, pantoprazole, lansoprazole, rabeprazole, or esomeprazole monotherapy were evaluated. The most frequently prescribed PPI, the most common indication, the most reported ADE, the seriousness of AEs, and the countries reporting the highest ADE number were analyzed using 2D disproportionality analyses (e.g., reporting odds ratio (RORs)). <b>Results</b>: A total of 464 patients were included; 323 (69.6%) of them were stated as serious and 15 (3.2%) of them were stated as time-related to mortality. Most of the ADEs were reported for lansoprazole (45.9%). The most reported PPI-associated ADE was vomiting (8.8%). According to the RORs analysis, vomiting associated with PPI monotherapy was more likely to occur (RORs: 2.88, 95% CI: 2.09–3.96), which is followed by diarrhea, hypertrichosis, choking, and erythema. Additionally, medication errors were reported in 50 (10.8%) patients. <b>Conclusions</b>: ICSR databases are valuable pharmacovigilance tools. The absence of access to a causality assessment is a limitation since it limits its ability to confirm whether the ADEs are truly caused by the suspected drug, mitigated using RORs analysis. Integrating neonatal-specific algorithms could enhance drug safety evaluations, strengthen evidence-based decision-making, and improve risk–benefit assessments in neonates and infants.https://www.mdpi.com/1424-8247/18/5/730drug safetyadverse drug eventmedication errorneonatesinfantsacid reducers |
| spellingShingle | Hülya Tezel Yalçın Nadir Yalçın Karel Allegaert Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions Pharmaceuticals drug safety adverse drug event medication error neonates infants acid reducers |
| title | Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions |
| title_full | Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions |
| title_fullStr | Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions |
| title_full_unstemmed | Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions |
| title_short | Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions |
| title_sort | real world safety profile of proton pump inhibitors in infants as reported in the fda adverse event reporting system faers tiny tummies key decisions |
| topic | drug safety adverse drug event medication error neonates infants acid reducers |
| url | https://www.mdpi.com/1424-8247/18/5/730 |
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