Motilium and other high-dose domperidone-based specialties will be withdrawn from the market on September 10 following a re-evaluation of the drug.
Medicines containing 20 mg of domperidone will be withdrawn from the market from September 10, 2014. This measure was taken after the European re-evaluation of Motilium carried out by the Belgian Medicines Agency, launched in March 2013. In fact, at high doses, Motilium has side effects that have caused serious cardiovascular events in recent years.
No more than 30 mg per day
The reassessment was completed in July 2014. In addition to the withdrawal from the market of specialties with high doses of domperidone, the European Medicines Agency is recommending new modes of use. In the first place, she recommends limiting the prescription of domperidone to relieve the symptoms of nausea and vomiting.
Possologies should also be controlled: no more than 0.75 mg in children and newborns and no more than 30 mg in adults and adolescents per day. The maximum duration of treatment is one week.
These recommendations were first made by the pharmacovigilance risk assessment committee (PRAC) of the European Medicines Agency in March 2014. They join those of the National Medicines Safety Agency, communicated one month. earlier.
Controversy following sudden deaths
These warnings follow the controversy launched by the medical journal Prescribe in February 2014. It denounced, in fact, the fact that this drug would have been responsible for 25 to 120 sudden deaths in France in 2012. According to these estimates, 3 million French people would use it every year
Motilium and its equivalents are also part of the black list of 63 drugs to avoid published at the end of January by the same review which called for the withdrawal from the market of this product.
The journal’s announcement then threw a stone in the pond and panicked Parkinson’s patients. The French Federation of Neurology and Parkinson’s expert centers then ensured that the benefit / risk balance remained favorable in the treatment of nausea and vomiting caused by antiparkinsonian treatments.
Adverse effects linked to domperidone-based medicines had already been reported: marketing authorizations were amended for the first time in 2004, then a second time in 2007.
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