Background: Excipients, inactive substances formulated alongside the pharmaceutical compound, have long been added to be part of drugs, and considered inert and pharmacologically inactive. However,as infants have immature hepatic and renal function, there have been more and more evidence suggesting some excipients may not be safe for infants, leading to their accumulation and resultant toxicity.
Methods: Literature retrieval was accessed through Medline 2.0 database (1860 to May 2014) using the search terms: drug additive and toxicity; drug additive and poison; excipient and toxicity; and excipient and poison. We found different numbers of journals respectively. Abstracts of these journals were reviewed, and excipients which had caused toxicity were recorded, and then we matched each excipient discovered with “toxicity,” through search of the same database,and found different numbers of journals related to the assorted matched pairs. Abstracts of these journals were reviewed again, and excipients, which had caused major toxicity or are not recommended for use in infants, were recorded. Results: Benzyl alcohol, propylene glycol, and ethanol, as safe excipients in medicines for adults,were noted to have induced major toxicity or even death in infants. Parabens and sodium metabisulphite drew inconclusive results.
Conclusion: Critically ill infants, especially those receiving multiple doses or medication by continuous infusion are at great risk. Constant observation and evaluation of medication used in infants is essential for drug safety.