Domperidone for nausea and vomiting is no longer licenced for use in children aged below 12 years or those weighing less than 35 kg, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
The announcement is following the publication of a new placebo-controlled study, which showed that the drug is not as effective as previously considered.
MHRA also cites a 2014 European safety review that confirmed the risk of serious cardiac adverse drug reactions, including sudden cardiac death, related to domperidone.
The government agency advised healthcare professionals to consider alternative treatment for children aged below 12-years and reminded that some physicians are not aware of the important precautions for the use of domperidone.
The recommended maximum dose of the drug in 24 hours is 30 mg, MHRA said.