Tezel Yalçın Hülya, Yalçın Nadir, Allegaert Karel
Department of Pharmaceutical Toxicology, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, Türkiye.
Department of Clinical Pharmacy, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, Türkiye.
Pharmaceuticals (Basel). 2025 May 16;18(5):730. doi: 10.3390/ph18050730.
: 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. : 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. : 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)). : 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. : 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.
质子泵抑制剂（PPIs）被广泛用于抑制胃酸分泌，但其在新生儿和婴儿中的疗效和安全性仍不明确。虽然埃索美拉唑是美国食品药品监督管理局（FDA）唯一批准用于1岁以下新生儿和婴儿的PPI，但其他PPIs也经常被处方使用。本研究利用FDA不良事件报告系统（FAERS）的数据来评估PPIs的潜在药物不良事件（ADEs），为其在这一脆弱人群中的安全性提供关键的真实世界见解。本观察性横断面研究使用个体病例安全报告（ICSR）数据库进行。仅评估接受奥美拉唑、泮托拉唑、兰索拉唑、雷贝拉唑或埃索美拉唑单药治疗的新生儿或婴儿的报告。使用二维不成比例分析（如报告比值比（RORs））分析最常处方的PPI、最常见的适应症、报告最多的ADE、不良事件的严重程度以及报告ADE数量最高的国家。总共纳入了464例患者；其中323例（69.6%）被列为严重事件，15例（3.2%）被列为与死亡时间相关。大多数ADEs报告与兰索拉唑有关（45.9%）。报告最多的PPI相关ADE是呕吐（8.8%）。根据RORs分析，PPI单药治疗相关的呕吐更有可能发生（RORs：2.88，95%CI：2.09 - 3.96），其次是腹泻、多毛症、窒息和红斑。此外，50例（10.8%）患者报告了用药错误。ICSR数据库是有价值的药物警戒工具。无法进行因果关系评估是一个局限性，因为这限制了其确认ADEs是否真的由可疑药物引起的能力，可使用RORs分析来缓解。整合针对新生儿的算法可以加强药物安全性评估，强化基于证据的决策制定，并改善新生儿和婴儿的风险效益评估。
