How to identify and manage ‘problem’ excipients in medicines for children

Children may be exposed to potentially harmful excipients, essential components of drug formulations, through unlicensed and off-label use of adult medicines. Excipient exposure should be minimised, although a medicine containing a problem excipient may be indicated, but only after a careful risk–benefit assessment.

Oral liquid formulations, such as solutions and suspensions, are commonly given to young children because they are easy to swallow. However, many liquid formulations have not been studied extensively, or authorised for paediatric use. This has resulted in the widespread routine clinical use of unlicensed medicines, and the use of adult medicines outside of their license, usually referred to as ‘off-label’ use, in children. 

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