Domperidone is a neuroleptic commercialised particularly for digestive disorders such as nausea and vomiting. It has not proved any more effective than a placebo, but it has been known for years that this drug can cause severe cardiac adverse effects.

At the end of 2011, following the examination of fresh consumption data, the French health products agency (ANSM) informed healthcare professionals of the severe cardiac disorders caused by domperidone: “an increased risk of severe ventricular arrhythmia and of sudden death […]”.

At the start of 2013, a re-evaluation of domperidone’s harm-benefit balance by the European Commission was instigated at Belgium’s request.

Domperidone is also sometimes used outside the approved indications, to stimulate lactation in breastfeeding. This use is not recognised by any health authority and it also presents risks: domperidone is secreted in breast milk and exposes newborns and infants, and their mothers, to cardiac arrhythmia.

Given domperidone’s unfavourable harm-benefit balance, it is not warnings but decisive action – i.e. the complete withdrawal from the market of medicines based on oral domperidone – that is required to protect patients. This is the logical next step after the withdrawal of the injectable form back in the 1980s.

In the meantime, it is better to avoid this neuroleptic which does a lot more harm than good.

©Prescrire 1 December 2013

"Domperidone and cardiac disorders: avoid this neuroleptic" Prescrire Int 2013; 22 (144): 297. (Pdf, subscribers only).