Nausea + Vomiting Medication
Domperidone: risk of cardiac side effects - restricted indication, new contraindications, and reduced dose and duration of use
Dear healthcare professional,
I am writing to inform you about important new information for domperidone (Motilium).
Domperidone is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of symptoms 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 below).
A recent Europe-wide review has recommended updates to the treatment advice for domperidone following evaluation of the benefits and risks of domperidone (see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/04/news_detail_002083.jsp&mid=WC0b01ac058004d5c1). The review was triggered following continued reports of cardiac side effects and a small increased risk of serious cardiac side effects was confirmed. A higher risk was observed in patients older than 60 years, adults taking daily oral doses of more than 30mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors concomitantly.
Advice for healthcare professionals
• Domperidone is now restricted to use in the relief of symptoms nausea and vomiting
• It should be used at the lowest effective dose for the shortest possible time
• Domperidone is contraindicated in people:
- with conditions where the cardiac conduction is, or could be, impaired
- with underlying cardiac diseases such as congestive heart failure
- receiving other medications known to prolong QT or potent CYP3A4 inhibitors
- with severe hepatic impairment
• Patients with these conditions should have their treatment reviewed at their next routine appointment and be switched to an alternative treatment if required
• For adults and adolescents over 12 years of age and weighing 35kg or more, the recommended maximum dose in 24 hours is 30mg (dose interval: 10mg up to three times a day)
Source : MHRA (April 2014)