- 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
- 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
Domperidone is a dopamine antagonist with anti-emetic properties. It is licensed for use in adults and in children 12 years and above. Phaeochromocytomas are rare tumours of the adrenal gland and are often diagnosed through incidental imaging.
A recent European review of safety data for domperidone identified an association between domperidone and episodes of severe hypertension in patients with phaeochromocytoma following a small number of reports of this event. As a result, recommendations have been made to update the product information to include a contraindication for use of domperidone in patients with phaeochromocytoma due to the risk of severe hypertension.
Domperidone and introduction of contraindication for use in phaeochromocytoma
The findings of the European review were considered by the UK’s Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM) who agreed with the recommendations and advised that the MHRA inform healthcare professionals and patients of this new contraindication.
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗