Parabens in over-the-counter drugs for pediatric use and their contribution to body burden

Parabens are commonly used as antimicrobial preservatives in consumer products, including over-the-counter (OTC) liquid medications. However, limited data are available on their occurrence in pediatric OTC drugs and their contribution to internal exposure in toddlers. 82 pediatric OTC liquid drugs from 13 countries were measured for four parabens and benzoic acid (BA). The use patterns and concentrations of parabens in the OTC liquid drugs varied by country: Korean samples (n = 19) contained all four parabens and BA, whereas U.S. samples contained only BA. Methyl paraben (MeP) and propyl paraben (PrP) were found at the highest levels in the drugs of Finland, Malaysia, and Korea. Estimated daily intakes (EDIs) based on prescribed dosages of pediatric OTC drugs in Korean toddlers were highest for MeP, followed by PrP and butyl paraben (BuP). The EDIs of MeP and PrP from OTC drugs in Korean toddlers approximated the 95th percentile of EDIs back-calculated from urinary paraben concentrations in national biomonitoring data (n = 578), whereas EtP and BuP did not show comparable levels. Moreover, the 95th percentile-to-median urinary concentration ratios for MeP and PrP in Korean toddlers were substantially higher than those in other countries, suggesting the presence of specific exposure sources, such as medication use, among the high-exposure group. Supporting this hypothesis, urinary MeP and PrP levels were positively correlated with medication use in the national biomonitoring data. Taken together, this study suggests that liquid medications are an important yet underrecognized source of high-level, albeit transient, paraben exposure in toddlers. As this exposure source is related to formulation choices, the use of alternative preservatives in pediatric medications could be considered to minimize unnecessary paraben exposure.