The European Medicines Agency (EMA) decided this week to re-evaluate the benefit / risk of several specialties including those based on domperidone. This molecule is marketed in France under the name Motilium, Peridys. Authorized in France since 1980, this medication is prescribed primarily to relieve symptoms such as nausea and vomiting in adults and children.
Due to an identified cardiac risk (rhythm disturbances), domperidone-based drugs have been the subject of regular pharmacovigilance monitoring for several years. In France, recalls the National Medicines Safety Agency (Ansm), “a letter was sent to health professionals in December 2011 to make them aware of this risk”. It is moreover the French and Belgian Agencies which are responsible for this evaluation. While awaiting the results, the Ansm asks prescribers to strictly follow the indications for this product and to take into account the cardiac risk in patients, in particular those with risk factors.
This EMA reassessment procedure is part of the strengthening of its pharmacovigilance system put in place last year with the creation of the PRAC. This pharmacovigilance risk assessment committee includes patient representatives. Their presence, underlines the Medicines Agency, makes it possible to take better account of the positions of civil society in the field of drug safety.
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