In 2013 and 2014, domperidone, antagonist of dopamine, was the subject of a European arbitration procedure on cardiac risk associated with its use, according to FAMHP.
In particular, it was considered that reducing the recommended dose of infants, infants, children and adolescents with a weight of less than 35 kg limited the cardiac risk: 0.25 mg / kg at most three times a day, compared to 0.25 mg / kg . at 0.5 mg / kg three to four times a day. A clinical study was also requested in children to evaluate the efficacy of the drug.
This study was stopped prematurely, says FAMHP: the results did not show a "significant benefit compared to a placebo treatment."
Motilium, the holder of the reference medicine and the marketing authorization, has therefore proposed abolishing the indication of domperidone for this juvenile audience. This was accepted by FAMHP and the other European Member States in question.
As a result, as of September 15, the "oral suspension Motilium 1 mg / ml" with dosing pipette, the only specialty aimed at the pediatric population less than 12 years old, is withdrawn from the market ". of the Agency. .
For adults and adolescents (after 12 years of age or more 35 kg), the dose is 10 mg up to three times a day, with 30 mg as a maximum daily dose.