Objective Adult formulations of medicines are frequently administered to children. Excipients are often described as ‘inactive ingredients,’ yet they can exert pharmacological, and possibly toxic, effects. The objective was to review the suitability of formulations given to children and neonates, by identifying excipients within medicines administered and evaluating the literature for adverse drug reactions associated with each.
Method Medicines administered to children and neonates were reviewed over 4 weeks in January to February 2010. Every time a medicine was administered the drug name, brand or manufacturer and dose prescribed were recorded. Data were collected within general paediatric and emergency care assessment wards and within a level three neonatal unit (NNU). The excipients within each medicinal product administered were found using the SPC, or by contacting the manufacturer directly. The suitability of each individual excipient was assessed following literature review.
Results 759 doses of medicine were logged. 80 different medicines were administered. 44 excipients were identified that were potentially unsuitable for use in children and neonates. From a literature review of the relative safety of each excipient they were grouped into four classes. Excipients that have potential harmful effect, which should be considered when prescribing. These included: acetone, aspartame, benzoic acid, benzyl alcohol, chloroform, citric acid, ethanol, galactose, methylhydroxybenzoate, phenol, polysorbate 20 and 80, propylene glycol, sodium benzoate, sodium bicarbonate, sodium chloride and sodium dihydrogen phosphate. Excipients with potential harmful effects only in extremely high concentrations. These included: diethanolamine, disodium edetate, hydrochloric acid, sodium carbonate anhydrous, sodium hydroxide, sucrose, sulphuric acid and triethyl citrate.
Excipients with potential to affect the gastrointestinal tract in excess and cause flatulence or act as a laxative. These included: carboxymethylcellulose sodium, croscarmellose sodium, hypromellose, magnesium stearate, maltitol liquid and mannitol. Excipients with potential to cause an adverse drug reaction, such as hypersensitivity and anaphylaxis. These included: cetyl alcohol, lactose, polyoxyethylene hydrogenated castor oil, potassium sorbate, propylhydroxybenzoate and butylhydroxybenzoate, protamine sulphate, saccharin sodium, sodium lauryl sulphate, sodium metabisulphate, sorbitol and tragacanth. On paediatric wards some products contained up to five potentially harmful excipients. On NNU most products used contained only one potentially harmful excipient.
Conclusion Excipients used within medicinal products that are given to children and neonates, often from adult formulations, may not be safe. The quantity of each excipient should be advertised on each medicinal product to enable an informed choice to be made on its relative safety in the neonatal and paediatric setting.
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