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<p>Medications contain excipients that may potentially cause toxicity in neonates. This study was aimed at examining recessive exposure of excipients of interest (EOIs) in a tertiary hospital in China. Data on all medicines administered to neonates along with demographic data were extracted from hospital medical records. Lists of excipients and their quantities were collected from the package inserts. EOIs were found in 39 medicines (30.5%) administered to 1473 neonates (96.6%), with disodium edetate being the most common harmful excipient, followed by polysorbate 80 (Tween 80). Benzalkonium chloride, sulfites, and Tween 80 were the three most common EOIs to which 1326 (87.0%), 1324 (86.8%), and 1046 (68.6%) neonates were exposed respectively. Sulfites, Tween 80, and ethanol were the three most frequently prescribed EOIs in 16,100 (62.4%), 10,001 (38.8%), and 8,468 (32.8%) prescriptions respectively. Neonates with lower birth weight (&lt;2500 g) were more likely to be exposed to a greater number of EOIs. Quantitative analysis showed that some neonates received doses exceeding the acceptable daily intake of sodium metabisulfite. EOI exposures were highly prevalent among neonates in the neonatal intensive care unit, which could potentially lead to excipient-related adverse reactions.</p>

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Recessive Prevalence of Potentially Harmful Excipients Used for Hospitalized Neonates in a Neonatal Intensive Care Unit: a Retrospective Study

  • 期刊论文

  • 发表日期：

    2025年11月1日

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  • Yang Zhang,
  • Yinying Zhang,
  • Ye Li,
  • Xiaoyan Yao,
  • Chuling Hu,
  • Li Ni

摘要

Medications contain excipients that may potentially cause toxicity in neonates. This study was aimed at examining recessive exposure of excipients of interest (EOIs) in a tertiary hospital in China. Data on all medicines administered to neonates along with demographic data were extracted from hospital medical records. Lists of excipients and their quantities were collected from the package inserts. EOIs were found in 39 medicines (30.5%) administered to 1473 neonates (96.6%), with disodium edetate being the most common harmful excipient, followed by polysorbate 80 (Tween 80). Benzalkonium chloride, sulfites, and Tween 80 were the three most common EOIs to which 1326 (87.0%), 1324 (86.8%), and 1046 (68.6%) neonates were exposed respectively. Sulfites, Tween 80, and ethanol were the three most frequently prescribed EOIs in 16,100 (62.4%), 10,001 (38.8%), and 8,468 (32.8%) prescriptions respectively. Neonates with lower birth weight (<2500 g) were more likely to be exposed to a greater number of EOIs. Quantitative analysis showed that some neonates received doses exceeding the acceptable daily intake of sodium metabisulfite. EOI exposures were highly prevalent among neonates in the neonatal intensive care unit, which could potentially lead to excipient-related adverse reactions.