The review of domperidone was initiated on 01 March 2013 at the request of the Belgian medicines authority, over concerns about the medicine’s effects on the heart. Serious cardiac effects were previously evaluated by the EMA’s former Pharmacovigilance Working Party and product information was updated in 2011; cases still however continued to be reported and the PRAC was asked to re-examine the issue.
The MHRA issued advice regarding the small risk of ventricular arrhythmia and sudden cardiac death associated with domperidone in May 2012 – this advised that it be used at the lowest effective dose, and listed a number of cautions to be taken into account when prescribing it. The MHRA have not yet issued any guidance following the new recommendations from the PRAC; final guidance from the EMA is awaited.
Based on their review, the PRAC has recommended the following:
• Domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting only. They should no longer be authorised to treat other conditions such as bloating or heartburn.
• The recommended dose should be reduced to 10mg up to three times daily by mouth for adults and adolescents weighing 35kg or more (these patients may also be given the medicine as suppositories of 30mg twice daily).
• Where the medicine is licensed in children and adolescents weighing <35kg, it should be given by mouth at a dose of 0.25mg/kg up to three times daily. Measuring devices should be included with liquid formulations to allow accurate dosing by bodyweight.
• The medicine should not normally be used for longer than one week.
• Domperidone must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects. In addition, it must not be used with other medicines that have similar effects on the heart or reduce the metabolism of domperidone.
The PRAC recommendation will be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its meeting in April 2014.