The PRAC of the European Medicines Agency is considering measures to limit the risks of medicinal products containing domperidone such as Motilium or Peridys.
In March 2013, at the request of Belgium, the European Medicines Agency (EMA) decided to reassess the benefit / risk of domperidone-based molecules. Due to an identified cardiac risk, these drugs, prescribed mainly to relieve symptoms such as nausea and vomiting, have been the subject of regular pharmacovigilance monitoring for several years. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency met from 2 to 5 December 2013 in London. PRAC has therefore just recommended the implementation of risk minimization measures for drugs containing domperidone.
A heart risk confirmed once again
Marketed in France under the name Motilium, Peridys and their generics, these gastric motor stimulants have been authorized since 1980. In some EU member states (this is not the case in France) these drugs are available without a prescription and there is no marketing authorization in others. While in 2011, in particular following discussions by the European Pharmacovigilance Group, changes were made to the summary of product characteristics (SPC), cases of cardiac adverse effects continue to be reported. The responses from laboratories and external contributors were analyzed by France and Belgium and discussed at the PRAC in July 2013, for the first time, then during the meeting which has just been held this week. In view of the data analyzed, the PRAC has therefore just confirmed the cardiac risk profile of drugs containing domperidone. In order to be able to put in place adequate risk minimization measures, in particular as regards the optimal dosage and duration of treatment and the measures to be taken on the different presentations existing in the EU, a complementary list of questions has been added. been developed.
ANSM recalls the usual precautions
Pending the final PRAC recommendation on this arbitration (scheduled for March 2014), ANSM recalls that domperidone is already known to cause heart problems. It is important to use it with caution in patients with risk factors. On the other hand, the Agency specifies in a press release that it is advisable to use Motilium, Peridys and their generics at the minimum effective dose and for the shortest possible duration. In December 2011, the ANSM had already sent a letter to health professionals to make them aware of this risk.
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