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Safety Information

Published: 31 March 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

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

Search for data sheet information

Products Affected

Product name Sponsor
Motilium Janssen-Cilag (New Zealand) Ltd
Prokinex Air Flow Products Limited

Additional Information

Information for consumers and caregivers
Information for healthcare professionals

Information on the previous review of this topic may be found in the minutes from the 120th Medicines Adverse Reactions Comittee meeting.

A Prescriber Update article has been published about drug-induced QT prolongation and medicines that cause QT prolongation.

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).

How to report an adverse reaction

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