Domperidone poses risk of heart death, U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), just announced.
Citing epidemiological studies, the agency announced that domperidone may be associated with a small, increased risk of serious ventricular arrhythmia or sudden cardiac death. These risks appear to increase in patients who are older than 60 years o age and who receive daily oral doses of more than 30 mg.
In the U.K., non-prescription domperidone products are also not recommended for use in patients with underlying cardiac disease without medical supervision, the MHRA pointed out.
Domperidone is a dopamine antagonist with anti-emetic (anti-vomiting, anti-nausea) properties. In Britain, domperidone is available as a prescription-only medicine with a maximum oral dose of 80 mg and is approved for nausea and vomiting, epigastric sense of fullness, and upper abdominal discomfort, as well as for the regurgitation of gastric contents in adults. Domperidone is also available in the U.K. without a prescription in pharmacies at lower doses—daily: 10 mg; maximum dose: 40 mg—for the treatment of minor gastrointestinal symptoms and nausea and vomiting in patients aged 16 years of age and older. The duration of non-prescription treatment should not exceed two weeks.
In the U.S., domperidone is not approved by the FDA for any purpose.
The MHRA explained that QTc prolongation and ventricular arrhythmia are known cardiac risks for all domperidone-containing products and that a recent European review revealed that domperidone may be associated with a small, but increased risk for serious ventricular arrhythmia or sudden cardiac death. In the U.K., the Commission on Human Medicines advised that non-prescription domperidone products are not recommended for use in patients with underlying cardiac disease without medical supervision.
In the U.S., the FDA previously warned healthcare professionals and breastfeeding women not to use the unapproved drug, domperidone, to increase milk production (lactation) after learning that some women were purchasing the drug from compounding pharmacies and foreign sources. Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women. Regardless, some web sites devoted to breastfeeding and lactation urge the use of this unapproved drugs and provide information on its purchase outside of the U.S.
The FDA noted that several published reports and case studies of cardiac arrhythmias, cardiac arrest, and sudden death were observed in some patients receiving an intravenous form of domperidone that was withdrawn from marketing in several countries. The U.S. agency also said it was aware of domperidone use by lactating women to increase breast milk production because of its effect on prolactin levels.
Domperidone is sold under the brands Motilium, Motinorm Costi, and Nomit.