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A new FAERS analysis raises concern over the safety of PPIs in infants, showing that drugs like lansoprazole increase the risk of adverse events such as vomiting and call for closer evaluation of their use in early life.
Proton pump inhibitors (PPIs) are commonly prescribed to manage gastric acid disorders (like gastroesophageal reflux disease [GERD]) in neonates and infants, yet their safety and effectiveness in this delicate age group remain uncertain. Despite esomeprazole being the only Food and Drug Administration (FDA)-approved PPI for children under 1 year, other agents are frequently used off-label in clinical practice. Recognizing this gap, Hülya Tezel Yalçın et al. aimed to analyze data from the FDA Adverse Event Reporting System (FAERS) to identify potential adverse drug events and offer real-world insights into the safety profile of PPIs in this population.
This observational cross-sectional study evaluated FDA individual case safety report (ICSR) data for neonates and infants treated with omeprazole, pantoprazole, lansoprazole, rabeprazole, or esomeprazole as monotherapy. Comprehensive analyses were executed via two-dimensional disproportionality methods and reporting odds ratios (RORs) to detect potential safety signals. Key variables included:
This structured approach provided real-world insights into the safety profile of PPIs in early-life populations. The study analyzed 464 neonatal and infant cases, uncovering critical safety insights into PPI use in early life.
Disproportionality analysis revealed a strong connection between vomiting and PPI monotherapy (ROR: 2.88; 95% confidence interval: 2.09–3.96), signaling a notable safety concern. Moreover, medication errors occurred in 10.8% (50 cases). The study spotlighted key safety risks of PPI use in neonates and infants, with ROR analysis revealing significant AE links. Despite limited causality confirmation, the findings underscored the need for neonatal-specific monitoring to boost drug safety and strengthen pharmacovigilance.
Pharmaceuticals (Basel)
Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions
Hülya Tezel Yalçın et al.
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