By reconciling the data from the Health Insurance and the frequency of sudden deaths in France, the journal Prescrire estimates that 25 to 120 sudden deaths are attributable to Motilium in 2012.
Since 2005, several Dutch and Canadian epidemiological studies have shown that sudden cardiac deaths are approximately 1.6 to 3.7 times more frequent in the event of exposure to domperidone, a substance contained in the anti-emetic agent Motilium and its generics. Even before specifying the risks attributable to this famous drug, in its article published this Wednesday, the journal Prescrire recalls that it is not even very effective in combating its main indication, namely nausea and vomiting. In this context, the independent medical journal therefore requests that the health authorities withdraw this molecule from the market once and for all.
At least 3 million French people took Motilium in 2012
In his analysis published today based in particular on data from health insurance, the editorial staff of “Prescrire” estimates that about 7% of the general population received at least one dispensation of domperidone in 2012, or about 3 million people. Among children, this proportion would be even greater, with 18% of 0 to 4 year olds concerned. But more worrying still, this work reveals that approximately 23% of these people received the same day a prescription of another drug known to potentially increase the risk of arrhythmia under domperidone.
Between 25 and 120 deaths in 2012, maybe more …
In order to more precisely quantify the risk of sudden death due to this drug in the French population, the drafting of Prescribe therefore cross-referenced data from Health Insurance with the latest studies on the increased risk of sudden death under domperidone. First of all, taking as a starting point the Canadian study giving a frequency of sudden death about 60% higher than normal under the effect of the drug, the authors estimate that in 2012 about 25 deaths would be directly to him. accountable. Finally, based on Dutch studies highlighting an even greater risk, the review’s analysis Prescribe brings this number of potential and preventable deaths to around 120. Although the authors of this work themselves admit that these figures may be overestimated because patients do not always take their treatment for the full length of time prescribed, they argue, it is especially possible, that they are in reality rather underestimated. Deaths in cancer patients, twice as exposed to this drug as the general population, are not included in this study, nor potential deaths probably occurred in a few children.
A European decision expected in March 2014
While at the end of 2011, the French Medicines Agency (ANSM) and the main laboratory concerned informed doctors and pharmacists of this risk of sudden death, for the review Prescribe it is now urgent that this drug be withdrawn from the market. In March 2014, the European Medicines Agency is also supposed to pronounce on the fate of domperidone. However, still according to the independent review, it is to be feared that it is content to recommend reductions in dosage or duration of treatment. Insufficient measures to fully protect patients. “It is high time to put this drug out of care, which can easily be replaced by better solutions for patients. In practice, often, the disorders which motivate the taking of domperidone disappear spontaneously, or with the addition of dietary measures ”specifies the review.
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