The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert reminding prescribers that domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg.
A European review of the safety of domperidone resulted in new restrictions being put in place in 2014 following continued reports of cardiac side effects.
Subsequently a multicentre, double-blind, randomised, placebo-controlled, parallel-group, prospective study evaluated the safety and efficacy of domperidone in 292 children with acute gastroenteritis aged between six months and 12 years (median age 7 years).
The study found domperidone did not deliver any benefit over placebo for reducing vomiting episodes during the first 48 hours after the first treatment administration. However, the study did not reveal any new safety concern.
A European review of this new evidence concluded that domperidone is not as effective in this population as previously considered. Consequently, the product information for UK domperidone medicines has been updated to remove the indication in children younger than 12 years of age.
However, the MHRA says recent regulatory studies in several European countries, including the UK, show a proportion of physicians are not aware of the changes in indication and the contraindications introduced in 2014.
Based on extrapolation from CPRD data, the agency estimates that 5,700-7,500 children aged 0-11 years were prescribed domperidone in the UK in 2018 for any indication.
Hence, the MHRA has reminded prescribers that domperidone is only indicated for adults and adolescents 12 years of age or older and weighing 35 kg or more. The recommended maximum dose in 24 hours is 30 mg (dose interval: 10 mg up to 3 times a day).