Published: 31 March 2014
Safety Information
Early Warning System - Monitoring Communication
Domperidone (Motilium, Prokinex) and effects on the heart
31 March 2014
Domperidone (Motilium, Prokinex) is used for relief of symptoms of nausea and vomiting, delayed gastric (stomach) emptying, reflux (regurgitation of stomach contents) and oesophagitis (swollen or inflamed windpipe).
The Pharmacovigilance Risk Assessment Committee (PRAC), part of the European Medicines Agency, has recently recommended restricting the dose and duration of use of domperidone in Europe due to the risk of QT prolongation (alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats).
PRAC recommendation regarding domperidone-containing medicines (PDF 73 KB, 3 pages)
Medsafe has previously reviewed this safety concern and is currently reviewing the new information.
In the interim, Medsafe reminds prescribers that domperidone should not be used with medicines that prolong the QTc interval or with medicines that inhibit CYP3A4 (increases plasma domperidone levels). In addition, domperidone should not be used in patients with moderate to severe hepatic impairment.
Domperidone should be initiated at the lowest effective dose. The maximum dose in adults and adolescents weighing greater than 35 kg is 80 mg per day.
The New Zealand data sheets and consumer medicines information (CMI) contain detailed advice on how to take domperidone and possible side effects.
Search for consumer medicine information
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Products Affected
| Product name | Sponsor |
|---|---|
| Motilium | Janssen-Cilag (New Zealand) Ltd |
| Prokinex | Air Flow Products Limited |
Additional Information
Information for consumers and caregivers
- For most people, taking domperidone is safe. However, if you have heart problems, you should check with your healthcare professional that this medicine is appropriate.
- If you experience any symptoms of abnormal heart rhythms such as dizziness, fainting or heart palpitations while you are taking domperidone, you should stop taking this medicine and seek medical attention.
- Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.
Information for healthcare professionals
- The overall benefit-risk balance of domperidone remains positive.
- Discuss the benefits and risks of domperidone treatment with patients before commencing therapy.
- Patients receiving long-term therapy with domperidone should be regularly reviewed for effectiveness, adverse effects and development of cardiovascular risk factors.
Regulator Actions
Medsafe is continuing to review this safety concern and will provide further information once this review is complete.
Reporting
Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).
