Alcohol use in paediatric medication: potential impact on the brain and the current regulation

Alcohol is an organic solvent that can interfere with neurological function. It is frequently used as an excipient in liquid medication as a solubiliser, preservative, and odorant. The addition of alcohol to liquid medicines, especially for paediatrics, has potential risks as some alcohol metabolizing enzymes are not fully expressed in some subpopulations of paediatrics. Accumulation of alcohol in the blood interferes with normal brain function. Major medicine agencies such as the Food Drug Administration (FDA) and the European Medicine Agency (EMA) recommend the limitation of the alcohol content in paediatric drug formulations to prevent alcohol toxicity in children. However, this recommendation has been underappreciated. This review aims to explore the current regulations on alcohol restriction in paediatric medication and the application of these regulations across different countries. The halal aspect of alcohol content in the medication was also discussed. This review will improve the understanding of the potential risk of alcohol in children as well as support the safety of liquid formulations for infants and toddlers.