Domperidone: updated safe prescribing advice

  • Domperidone is associated with a small increased risk of serious cardiac side effects.
  • Following an MHRA Drug Safety Alert in May 2014 its licensed indications are now restricted to the relief of nausea and vomiting, and the dosage and duration of use have been reduced. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors (see MHRA alert for full details).
  • All patients receiving long-term domperidone should have their therapy reviewed and risks explained to them.
  • A trial of withdrawal of domperidone therapy should be tried in all patients, with full patient engagement.
  • The MHRA recommended that domperidone be restricted to a maximum dose of 10mg up to three times daily for a general indication of nausea and vomiting in adults.
  • Overall, the benefit to risk was considered to be positive for other indications. It was also considered that well-established paediatric use should continue, but recommended dose reductions.
  • For GORD or dyspepsia, ensure all other therapeutic and lifestyle options are optimised.
  • Patients of any age with gastro-oesophageal symptoms that are persistent, non-responsive to treatment or unexplained should be considered for referral to a specialist.
  • For gastroparesis, ensure any iatrogenic cause is identified. Assess and correct nutritional state and, in patients with diabetes, check glycaemic control.
  • Long-term domperidone may still be an appropriate treatment option provided the risk/benefits for an individual patient have been assessed and informed consent has been obtained. Prescription will be limited to the following:
    • Definite functional outlet delay evidenced by endoscopy and/or transit study
    • Avoid in age > 60
    • NO significant heart disease, severe hepatic impairment, co-use of CYP3A4 inhibitors or QTc prolongating drugs or on pre-treatment ECG
    • Under regular review by clinician
    • Maximum dose 10mg tds
    • Trial of limited courses with drug “holidays”

The above information has been taken from the UKMI TRENT MEDICINES INFORMATION SERVICE and MHRA Drug Safety Update.