ANSM publishes a new warning against domperidone based medicines, because of a “rare but potentially serious cardiac risk”.
Attention danger. Medications based on domperidone ( Motilium and generics ) should no longer be administered to children under 12 years, said the National Agency for Medicines ( ANSM ) in a statement released Friday, June 28, 2019. The cause: its adverse effects and in particular a cardiac risk.
Domperidone is a medication prescribed for the relief of nausea and vomiting. The Agency recalls that domperidone has been closely monitored for several years.
“ANSM is closely monitoring this drug because of its side effects, including its rare but potentially serious cardiac effects (torsades de pointes), and regularly informs healthcare professionals.”
No more effective than a placebo
According to the health agency, a study requested in 2014 by the European Medicines Agency (EMA), whose results were presented recently, proves that domperidone is no more effective than placebo in children under 12 years old.
The use of Motilium (Janssen-Cilag laboratory) and its generics (Mylan, Teva, Biogaran laboratories, etc.) is now restricted to adults and adolescents weighing more than 35 kilos .
Use with moderation
The ANSM takes the opportunity to remind that the use of this medicine against nausea and vomiting must also be done with caution in adults. Thus, the dose is limited to 10 mg up to three times daily, with a maximum dose of 30 mg/day. The duration of treatment “should be as short as possible” and should not exceed one week.
Domperidone medicines are also contraindicated in patients with hepatic insufficiency and in certain situations that may lead to life-threatening cardiac abnormalities (heart disease, simultaneous use of other medications).
Health professionals are called to vigilance. Medications heavily dosed with domperidone (20 mg) have already been withdrawn from the market in 2014.