The pharmacovigilance committee of the European agency recommends reducing the current authorized doses and no longer prescribing Motilium for heartburn or bloating.
Motilium should not be withdrawn from the market, this is in any case the conclusion of the pharmacovigilance risk assessment committee (PRAC) of the European Medicines Agency which has just been made public on Friday. While the re-evaluation of the benefit / risk balance of Motilium has been underway for nearly a year, the PRAC therefore ultimately advises to keep drugs containing domperidone on the market, even if it recommends a restricted use of these drugs. treatments against nausea and vomiting marketed since 1980. While the independent journal Prescrire sparked a controversy last month calling for the withdrawal of this drug due to an increased risk of sudden death, the PRAC finally issued an opinion much less clear-cut.
No more than 1 week and reduce the oral dose to 30mg per day
After examining the available data, this committee therefore recommended, on the one hand, that Motilium should only be used for the treatment of nausea and vomiting and no longer for the relief of other gastric disorders such as heartburn and bloating. On the other hand, according to these experts, this drug should not be absorbed for more than a week and people with liver problems or heart rhythm disturbances should not take it. Finally, to preserve patient safety, the PRAC also considers that the dosages of Motilium should be reviewed. Thus, the recommended oral dose should be reduced to 10mg at most three times a day and to two suppositories of at most 30mg per day in adults or adolescents over 35kg. In children, in the few countries that allow it, these specialists recommend that the dose be 0.25 mg per kilo up to three times a day orally, on the other hand the data on the effectiveness of Motilium in suppositories in children seem to be limited at the moment.
Parkinson’s patients distraught by a potential withdrawal
Before the publication of this opinion, the French Federation of Neurology and Parkinson’s expert centers had indicated that they were totally opposed to a withdrawal from the market. According to neurologists, domperidone maintains a favorable risk / benefit balance in the treatment of nausea and vomiting caused by antiparkinsonian drugs. Moreover, it is following a large and growing number of calls from patients distraught by the controversy launched in February by the journal Prescrire, that neurologists were keen to highlight the benefits provided by domperidone in these patients.
Listen to Prof. Pierre Pollak, head of the neurology department of the CHU de Genève: “ The benefit of domperidone in people with Parkinson’s is considerable, as it prevents the peripheral effects of antiparkinson drugs and improves their tolerance. “
If Motilium were to be withdrawn from the market, these patients with Parkinson’s disease would find themselves in a therapeutic impasse. “Without this drug, we would have to give other less effective anti-nausea treatments. Either metoclopramide which aggravates Parkinson’s disease, or others which have not shown their effectiveness in this pathology and which, moreover, have the same potential cardiac effects as domperidone ”specifies Pr Pollak who is also Chairman of the scientific committee of the France Parkinson association. Thus, for neurologists, the new European recommendations for restriction of use and not withdrawal, are more in the right direction. However, if the French Medicines Safety Agency (ANSM) followed them to the letter, this could still pose a problem for Parkinson’s patients in terms of dosage.
Listen to Prof. Pierre Pollak: ” I will not hesitate to go up to 60 mg per day for the first few days of treatment, if I am dealing with a patient who has a healthy heart and a normal ECG. “
The PRAC recommendation will be examined in April by the body representing the various national drug agencies in EU countries, for a final opinion. The ANSM had announced that it was awaiting the opinion of the PRAC to make a decision at the national level. Last February, the Agency also published a warning on the use of Motilium for prescribers. She recalled that the cardiac risk was higher in patients over the age of 60 or in those who were treated with daily doses greater than 30 mg.
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