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. 2018 Feb;38(2):169-174.
doi: 10.1038/jp.2017.165. Epub 2017 Nov 2.

Excipient exposure in very low birth weight preterm neonates

T O Akinmboni  1 , N L Davis  1 , A J Falck  1 , C F Bearer  1 , S M Mooney  1
Affiliations

Excipient exposure in very low birth weight preterm neonates

T O Akinmboni et al. J Perinatol. 2018 Feb.

Abstract

Objective: The excipients benzyl alcohol, propylene glycol and ethanol are present in medications used in the neonatal intensive care unit. Exposure to high levels can have adverse effects in a neonatal population. The objective was to quantify excipient exposure in very low birth weight (VLBW) neonates and identify risk factors associated with greater exposure.

Study design: A retrospective record review of VLBW infants admitted over 1 year. Excipient exposures were calculated and multivariable regression analyses identified risk factors for increasing exposure.

Results: In total, 98% of subjects were exposed to at least one excipient. A total of 5 to 9% received doses higher than recommended for adults. Necrotizing enterocolitis, seizure, bronchopulmonary dysplasia and longer stay predicted higher excipient exposure.

Conclusion: The excipients examined are in medications commonly prescribed for VLBW neonates, and cumulative doses may exceed recommended exposures for adults. Although safety profiles have not been established, judicious use of medication containing these excipients is warranted for this population.

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Conflict of interest statement

Conflict of Interest: The authors have no conflicts of interest relevant to this article to disclose.

Figures

Figure 1
Figure 1. Median Daily Excipient Exposure
Daily median exposure to each excipient for all subjects in the cohort shown in order of increasing exposure. Triangles denote females and squares show males. Dashed lines show acceptable daily intake levels for adults for BA and PG determined by the Joint Food and Agriculture Organization of the United Nations and the World Health Organization Expert Committee on Food Additives.
See this image and copyright information in PMC

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