Domperidone: Restriction of use in paediatric patients less than 12 years of age

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Overview

Domperidone is a dopamine antagonist indicated for the relief of the symptoms of nausea and vomiting. It is thought to exert its antiemetic effect through antagonism of dopamine receptors in the gut and the chemoreceptor trigger zone. Studies have shown that oral domperidone increases lower oesophageal pressure, improves antroduodenal motility and accelerates gastric emptying.1

Currently, there are 13 domperidone-containing products (as tablet and oral suspension) registered in Malaysia.

 

Background

In 2014, the European Medicines Agency (EMA) reviewed the safety of domperidone-containing products due to its association with the risk of serious and potentially life-threatening cardiovascular adverse effects such as ventricular arrhythmias and sudden cardiac death.2 Based on the review, the benefit-risk balance of domperidone remains favourable for the relief of nausea and vomiting symptoms. At that time, there were limited data to support the efficacy of newly recommended dose of domperidone (0.25 mg/kg three times a day or up to 30 mg/day) for the relief of symptoms of nausea and vomiting in children. Following this, EMA had requested the product registration holder of domperidone to conduct a study to generate robust data on domperidone efficacy in children.

In 2019, results from a randomised controlled study showed that the use of domperidone in children below 12 years of age with acute gastroenteritis (in combination with oral rehydration therapy) showed no difference in efficacy when compared to placebo. Based on this study, the product registration holder of domperidone has updated the product package insert and removed the use of domperidone in children below 12 years of age with body weight less than 35 kg.3*

 

*The dosing for children below 12 years of age weighing more than 35 kg is not affected as dosing of this population is not weight based.

 

In Malaysia, NPRA has completed a review of this safety issue and a directive [Ruj. Kami: (6) dlm. BPFK/PPP/07/25 Jld. 4] has been issued for registration holders of domperidone products to update the local package inserts and consumer medication information leaflet (Risalah Maklumat Ubat untuk Pengguna) to reflect this safety information.

 

Advice for Healthcare Professionals:

  • Domperidone should not be used in infants and children less than 12 years of age who weighs less than 35 kg due to lack of efficacy evidence in this population.
  • Domperidone is contraindicated in :
    • Patients with known existing prolongation of cardiac conduction intervals;
    • Patients with significant electrolyte disturbances or underlying cardiac diseases;
    • Patients concomitantly taking QT-prolonging drugs or potent CYP3A4 inhibitors.
  • Be alert on the risk of serious cardiac adverse reactions associated with the use of domperidone.
  • Domperidone should be taken at the lowest effective dose for the shortest duration possible. The usual maximum treatment period should not exceed one (1) week.
  • Report all suspected adverse events associated with domperidone-containing products to the NPRA.

 

References:

  1. Domperidone Malaysian product package insert [Last revision date: April 2018].
  2. European Medicines Agency (2014). PRAC recommends restricting use of domperidone. EMA/129231/2014.
  3. Leitz G et al. (2019). Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children. J Pediatr Gastroenterol Nutr 69(4):425-430.

 

 

DISCLAIMER:

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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