A European Medicines Agency (EMA) review of the safety of domperidone published in 2014, revealed there was a lack of data supporting paediatric use of the drug in the relief of nausea and vomiting. As a result, the EMA requested studies to provide robust data to support the efficacy in children.
In a recent double-blind, placebo-controlled, phase 3 study, 292 children with acute gastroenteritis aged between 6 months and 12 years were randomised to receive oral rehydration treatment (ORT) and either domperidone oral suspension at a dose of 0.25mg/kg, or placebo, three times a day for up to 7 days.
The proportion of patients with no vomiting episodes within 48 hours of the first treatment dose (primary endpoint) was similar between the domperidone and placebo groups (32% vs 33.8%, respectively).
Since the results of this study did not show domperidone to be more effective than placebo, the MHRA has restricted the drug's licensed indication to relief of nausea and vomiting in adults and adolescents 12 years of age or older and weighing 35kg or more.
Reminder on safe use
The MHRA Drug Safety Update also includes information on contraindications and recommendations for dose and treatment duration to remind healthcare professionals on the safe use of domperidone.