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<p>This study addresses a significant gap in evaluations of the safety of antibacterial drugs in infants aged 0–1&#xa0;year on the basis of a comprehensive pharmacovigilance analysis. We use data spanning the period from 2005Q1 to 2025Q1, which we obtain from the FDA Adverse Event Reporting System (FAERS) to retrospectively assess adverse events (AEs) associated with three commonly used antibacterials—vancomycin, cefotaxime, and gentamicin—in this vulnerable population. A total of 698 cases of AE were included in the study. Disproportionality analyses (which rely on the reporting odds ratio (ROR), proportional odds ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-item gamma Poisson shrinker (MGPS)) revealed significant AE signals with multiple testing correction using a 5% false discovery rate: vancomycin and gentamicin were predominantly associated with acute kidney injury (<i>n</i> = 50, ROR = 16.18, 95% CI 12.13–21.59, <i>P</i> = 3.16e − 41; <i>n</i> = 12, ROR = 21.18, 95% CI 11.82–37.95, <i>P</i> = 1.95e − 12), whereas cefotaxime was linked to increased alanine aminotransferase (<i>n</i> = 4, ROR = 7.72, 95% CI 2.87–20.75, <i>P</i> = 0.002) and aspartate aminotransferase levels (<i>n</i> = 4, ROR = 7.51, 95% CI 2.79–20.19, <i>P</i> = 0.002), thus indicating liver injury. Gentamicin was also associated with neurosensory deafness (<i>n</i> = 6, ROR = 146.47, 95% CI 63.31–338.83, <i>P</i> = 8.85e − 12). A Weibull distribution analysis of onset timing showed that the risk of AEs for all three antibacterials remained consistent over time. These findings underscore the increased vulnerability of infants to drug toxicity. These results emphasize the critical need for cautious, individualized risk–benefit assessments in the context of prescribing antibacterials to infant patients.</p>

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Evaluating adverse events of antibacterials in infants: insights from FDA adverse event reporting system (FAERS) data

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月8日

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  • Kai Yan,
  • Guang Yang,
  • Lixuan Yan,
  • Li Wu,
  • Yang Wang,
  • Peifeng He,
  • Qi Yu

摘要

This study addresses a significant gap in evaluations of the safety of antibacterial drugs in infants aged 0–1 year on the basis of a comprehensive pharmacovigilance analysis. We use data spanning the period from 2005Q1 to 2025Q1, which we obtain from the FDA Adverse Event Reporting System (FAERS) to retrospectively assess adverse events (AEs) associated with three commonly used antibacterials—vancomycin, cefotaxime, and gentamicin—in this vulnerable population. A total of 698 cases of AE were included in the study. Disproportionality analyses (which rely on the reporting odds ratio (ROR), proportional odds ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-item gamma Poisson shrinker (MGPS)) revealed significant AE signals with multiple testing correction using a 5% false discovery rate: vancomycin and gentamicin were predominantly associated with acute kidney injury (n = 50, ROR = 16.18, 95% CI 12.13–21.59, P = 3.16e − 41; n = 12, ROR = 21.18, 95% CI 11.82–37.95, P = 1.95e − 12), whereas cefotaxime was linked to increased alanine aminotransferase (n = 4, ROR = 7.72, 95% CI 2.87–20.75, P = 0.002) and aspartate aminotransferase levels (n = 4, ROR = 7.51, 95% CI 2.79–20.19, P = 0.002), thus indicating liver injury. Gentamicin was also associated with neurosensory deafness (n = 6, ROR = 146.47, 95% CI 63.31–338.83, P = 8.85e − 12). A Weibull distribution analysis of onset timing showed that the risk of AEs for all three antibacterials remained consistent over time. These findings underscore the increased vulnerability of infants to drug toxicity. These results emphasize the critical need for cautious, individualized risk–benefit assessments in the context of prescribing antibacterials to infant patients.