Urgent need to standardize labelling of acetaminophen-paediatric liquid drug products in Saudi Arabia

Abstract

In this study, dosing instructions in package inserts of all 12 paediatric liquid acetaminophen products registered in pharmacies in the Kingdom of Saudi Arabia were analysed to determine the potential for administering a supratherapeutic dose of acetaminophen. Doses in millilitres were calculated as mg/kg for four age groups: three months old, one year old, six years old, and twelve years old, and based on the 3rd, 50th, and 75th weight percentiles of each age group.

Acetaminophen concentrations in the products varied, and only two products included Arabic language instructions. The dosing instructions in eight products included an age overlap. The most affected age group was the 1-year-old group, with 21 supratherapeutic doses across all 12 products. The least affected age group was the 12-year-old group, with 8 supratherapeutic doses in total.

The absence of strict supervision and monitoring of labels of paediatric liquid acetaminophen products increases the risk of liver toxicity in children. Therefore, we call for an immediate standardisation of all dosing instructions regarding the dose per weight and the inclusion of instructions in Arabic.