MHRA Drug Safety Update: Domperidone new contraindication

MHRA Drug Safety Update: Domperidone: new contraindication in patients with phaeochromocytoma due to the risk of severe hypertension.

The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episodes of severe hypertension.

Advice for Healthcare Professionals:

  • a small number of reports have been received relating to severe episodes of hypertension in patients with phaeochromocytoma (a rare tumour of the adrenal gland) following administration of domperidone
  • domperidone is now contraindicated in patients with confirmed or suspected phaeochromocytoma
  • patients with confirmed or suspected phaeochromocytoma should stop taking domperidone immediately and be switched to an alternative treatment
  • be aware that administration of domperidone can unmask phaeochromocytomas. If a patient taking domperidone has an episode of severe hypertension, consider further investigations for phaeochromocytoma
  • domperidone should be used at the lowest effective dose for the shortest possible duration and maximum treatment duration should not usually exceed 1 week
  • for patients receiving palliative care, an individual benefit risk decision on treatment should be made in discussion with the patient
  • report suspected adverse drug reactions associated with domperidone via the Yellow Card scheme

Advice for Healthcare Professionals to Provide to Patients:

  • stop taking domperidone immediately if you have been diagnosed with phaeochromocytoma (a rare tumour of the adrenal gland) by your doctor. Speak to your doctor or pharmacist about alternative treatment options
  • seek medical attention immediately if you experience symptoms of severe high blood pressure. Symptoms can include, but are not limited to: persistent headache, blurred vision, shortness of breath and chest pain
  • report suspected adverse drug reactions associated with domperidone via the Yellow Card scheme

For further details, please view the full Drug Safety Update here.