In an analysis, Prescrire brings the number of potential and preventable deaths attributable to motilium to around 120. Because of the risk of sudden death, the ANSM issues a warning to doctors.
By reconciling the data from the Health Insurance and the frequency of sudden deaths in France in 2012, the journal Prescrire estimates that for this year alone 25 to 120 sudden deaths would be attributable to domperidone, this substance contained in the Motilium anti-emetic agent. and its generics. For this reason, the medical journal asked the health authorities to withdraw this molecule from the market. Especially since 2005, several epidemiological studies, Dutch and Canadian, have shown that sudden cardiac deaths are approximately 1.6 to 3.7 times more frequent in the event of exposure to domperidone. In this context, the Medicines Safety Agency (ANSM) has just published a warning on the use of the product for prescribers.
Risks of misuse
In its press release, the Agency recalls that following the observation of serious cardiac adverse effects, it wrote in 2011 to health professionals in order to inform them and make them aware of the “rare” but “potentially” cardiac risks. severe “(torsades de pointes) linked to the use of this molecule. At the same time, the ANSM indicates that it had already published a warning on the risks of certain misuse of Motilium and its generics. For example to stimulate lactation in women.
Thus, it specifies once again that Motilium is indicated only “in adults for the relief of symptoms such as nausea and vomiting, sensations of epigastric distension, discomfort in the upper abdomen and gastric regurgitation. Motilium is also indicated in children for the relief of symptoms such as nausea and vomiting. “
A short prescription and at the lowest possible dose
Faced with these dangers, the European Medicines Agency, with the Prac, has also initiated a reassessment of the benefits / risks of domperidone by a European arbitration initiated in March 2013, for which France is rapporteur.
But while awaiting the PRAC recommendations expected in March 2014, the ANSM is already recommending that precriptors strictly follow the indications for this product and take into account the cardiac risk, in particular in patients who present risk factors (existing prolongation of the QT interval, significant electrolyte disturbances, congestive heart failure, etc.)
In addition, it indicates to the doctors that at this stage of the reassessment, it is recommended that the doctors limit the prescription to the shortest duration of treatment (usually 7 days maximum), and to the lowest possible dose without exceeding 30 mg / day in adults. This is because the risk may be higher in patients over 60 years of age or in those treated with daily doses greater than 30 mg.
Finally, the Agency recommends on its website the following measures for patients: “in the absence of heart problems, patients currently on treatment can continue taking Domperidone. The treatment could possibly be reconsidered during a next consultation. The Agency will keep you informed of the results of the ongoing assessment, ”she concludes.
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