Excipient exposure in very low birth weight preterm neonates

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. 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. 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. 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.