The independent review Prescrire calls on the public authorities to withdraw from the market drugs based on domperidone, a molecule marketed in France under the name Motilium. Its use is dangerous for health and its effectiveness is limited.
“This antiemetic drug (which fights against nausea and vomiting) has modest effectiveness against common nausea and vomiting, but increases the risk of cardiac arrhythmias and sudden death,” says the journal Prescrire, which published a document on Wednesday. on this topic.
Marketed in France since 1980, the Motiliumhad already in 1986 made talk about him. Heart rhythm disturbances and even death led to the withdrawal of injectable domperidone from the market. But oral forms have remained authorized.
In March 2013, at the request of the Belgian health authorities, the European Medicines Agency decided to look into this medicine by carrying out a new benefit / risk assessment. Domperidone is suspected of causing undesirable cardiac effects, such as changes in the electrical activity of the heart as well as arrhythmias (irregular heartbeat).
Alarming Dutch and Canadian studies have also been published since 2005. They revealed that sudden cardiac deaths are about 1.6 to 3.7 times more frequent with exposure to domperidone.
The Motilium responsible for several deaths
According to the journal Prescrire, this drug would be responsible for 25 to 123 sudden deaths in 2012 in France. Despite these figures, 7% of French people are still at risk of death from this drug. 3 million people in France receive a prescription for Motilium.
In March, the French Medicines Agency (ANSM) is due to deliver its verdict on the risk benefits of domperidone. However, Prescrire is worried and thinks that the Agency “will be satisfied with recommending reductions in doses or in the duration of treatment. “” Measures “which would be for the review” insufficient to protect patients. “
