Ministry of Health of Peru

PRAC recommends restricting the use of Domperidone

Press Release
European Medicines Agency - EMA

March 20th, 2014 - 12:00 a. m.

The European Medicines Agency (EMA) reported through a press release the recommendations of
the Pharmacovigilance Risk Assessment Committee (PRAC) regarding the completion of the review
of medicines containing Domperidone, recommending changes in its use. Changes include using the
drug only to relieve symptoms of nausea and vomiting, restricting the dose, and carefully adjusting
the dose according to body weight. The recommendation to reduce the dose and duration of
treatment was considered key to minimizing its risks. The Domperidone review was initiated at the
request of the Belgian Medicines Authority, due to some concerns about the drug's effects on the
heart. The PRAC recommends that Domperidone-containing medicinal products should remain
available and can continue to be used in the European Union for the management of symptoms of
nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times
a day orally for adults and adolescents weighing 35 kg or more. These patients can also receive the
drug as 30 mg suppositories twice daily. When the medication is authorized in children and
adolescents weighing less than 35 kg, it must be administered orally at a dose of 0.25 mg per kg of
body weight up to three times a day. Likewise, measuring devices must be included in the
formulations. liquid to allow precise dosing by body weight. The drug should not be used for more
than a week. Domperidone should no longer be authorized for the treatment of other conditions such
as bloating or heartburn. It should not be used in patients with moderate or severe hepatic
impairment, or in those with existing abnormalities of electrical activity in the heart or heart rate.

Source https://www.gob.pe/institucion/minsa/noticias/66790-prac-recomienda-restringir-uso-de-
domperidona