Domperidone: Not for Under 12 Years
Drug Safety Update
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.
In 2019, 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. As a result, domperidone is no longer indicated for the relief of nausea and vomiting in children aged under 12 years.
Recommendations
Healthcare professionals are advised to adhere to the licensed dose and to use the lowest effective dose for the shortest possible duration (maximum treatment duration should not usually exceed 1 week).
Moreover, 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.
This update is practice changing. Has your facility adopted it?
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