Domperidone (Motilium° or other brands) is a neuroleptic used to treat the symptoms of common nausea and vomiting, with modest efficacy. Neuroleptics are known to expose patients to the risk of heart rhythm disorders. Since 2005, several epidemiological studies, conducted in the Netherlands and Canada, have shown that sudden cardiac death is about 1.6 to 3.7 times more frequent in patients exposed to domperidone.

In late 2011, the French drug regulatory agency and the main drug company that markets domperidone informed doctors and pharmacists about the risk of sudden death. The European Medicines Agency (EMA) is due to issue an opinion on domperidone in March 2014, but there is a chance it will simply recommend lower dosages or shorter treatment durations. These measures are insufficient to fully protect patients and would just shift the responsibility from drug regulatory agencies onto healthcare professionals, who have enough to do without having to explain to patients that a particular drug is authorised but should not be used.

Against this background, on Wednesday 19 February, Prescrire is publishing a study conducted by its editorial team using data from the French health insurance system. According to these data, domperidone was dispensed at least once to about 7% of French adults in 2012, i.e. about 3 million adults. Based on these data and the incidence of sudden death in France, using conservative assumptions, it is likely that about 25 to 120 sudden deaths were attributable to domperidone in France in 2012.

It is high time to stop the use of this drug that can easily be replaced by better solutions for patients. In practice, the disorders for which domperidone is prescribed are often self-limiting or resolve with dietary measures. For patients who nevertheless want drug therapy, one option is a truly harm-free placebo. For patients with gastroesophageal reflux disease, a proton pump inhibitor such as omeprazole (Prilosec° or other brands) is preferable to domperidone. And in the rare situations in which a gastric “motility modifier” appears justified, metoclopramide (Primperan° or other brands) can be discussed, but used with great caution: at the lowest effective dose, monitoring very closely for its adverse effects, given that this drug is also a neuroleptic. Metopimazine (Vogalene° or other brands) and alizapride (Plitican°) offer no demonstrated advantages over metoclopramide.

©Prescrire 19 February 2014

"Domperidone: an indication of how many sudden deaths in France could be prevented by avoiding this low-efficacy drug" Prescrire Analysis, 19 February 2014 (pdf, free)