Beyond the label: Excipients and neonatal safety.

Abstract

Pharmaceutical excipients are inactive ingredients of medicines, perceived to be harmless to the body or the drug. They exist for many purposes, including: • Preservatives (benzyl alcohol, parabens, sodium benzoate, sulfites) • Sweeteners (aspartame, saccharin, sorbitol) • Solvents (ethanol, propylene glycol) • Stabilising agents (polysorbates) Excipients may cause harm to neonates due to their unique physiology. For example, benzyl alcohol, used historically as a preservative in saline flushes led to ‘gasping syndrome’ and subsequent death in many babies due to immature metabolic pathways. Thus, it is crucial to understand the inactive excipients present in formulations used by neonates, and risks they pose.