Following a European review of new evidence showing a lack of efficacy for domperidone for nausea & vomiting in children, the MHRA have updated UK product information and have provided the following advice for healthcare professionals:
Change of indication
- domperidone is now authorised for the relief of symptoms of nausea and vomiting only in adults and adolescents 12 years of age or older and weighing 35 kg or more
- consider alternative treatments to domperidone in children younger than 12 years of age who need relief of symptoms of nausea and vomiting
The MHRA also remind healthcare professionals that domperidone is contraindicated in the following situations: where stimulation of gastric motility could be harmful (e.g: patients with gastro-intestinal haemorrhage, mechanical obstruction, or perforation); hypersensitivity to domperidone; moderate to severe hepatic impairment; known existing prolongation of cardiac conduction intervals (particularly QTc); underlying cardiac diseases such as congestive heart failure; significant electrolyte disturbances; a prolactin-releasing pituitary tumour; and during co-administration with QT-prolonging drugs or potent CYP3A4 inhibitors (regardless of their QT-prolonging effects).