The federal agency for medication and health products has ordered an end to the prescription of the drug domperidone, marketed as Motilium, for children under the age of 12 and adolescents weighing less than 35kg.
Motilium is an anti-emetic, used to quell feelings of nausea,in cases of stomach complaints. A dopamine antagonist, it was the subject of a Europe-wide study in 2013-2014 on the risks of heart problems associated with the drug. The study recommended reducing the dose for anyone under 35kg to 0.25mg, a maximum of three times a day.
Now the federal agency has found that the study was prematurely halted, and also that a study into the drug’s effectiveness has shown no positive results more significant that would be achieved with a placebo.
Motilium for paediatric use will therefore be withdrawn from the market from September, the agency said. The ban will operate Europe-wide. No similar product exists on the market as a substitute. “Consult a doctor and discuss an alternative approach,” commented Olivier Christiaens of the agency. “It is more than anything a question of addressing the underlying problem behind the symptoms. That can then be treated with another product or even without medication.”
The drug will still be available for use by adults and young people weighing more than 35kg, with a lowered dosage of 10mg three times a day, and a maximum daily dosage of 30mg.
The Brussels Times