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The use of domperidone in children was expected to decrease based on the results of a recent randomized controlled study (ClinTrials gov NCT02699385) that showed lack of effect at the approved pediatric dose (0 25 mg kg TID) and led to the removal of domperidone’s European indication for use in children --- ema europa eu en medicines human domperidone-containing-medicinesDomperidone is available over-the-counter in many countries, for instance in Europe and elsewhere throughout the world [19] [1] It is not approved for use in the United States [20] [21] [1] However, it is available in the United States for people with severe and treatment-refractory gastrointestinal motility problems under an expanded access individual-patient investigational new drug Overview On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human ( CMDh) endorsed recommendations to restrict the use of domperidone-containing medicines The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms Background and Objective Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies Although most physicians in five countries in the EU appear to be aware of risk-minimisation measures (RMM) for domperidone including changes to labelling due to the risk of arrhythmias and sudden cardiac death (heart arrest), and there has been improvement in compliance with the revised labelling in France, there appears to be little improvement in compliance in the other four countries pubmed ncbi nlm nih gov 31325111link springer com article 10 1007 s40278-019-65432-3Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe Clin Drug Investig 2019 Nov;39(11):1057-1066 doi: 10 1007 s40261-019-00831-3 en wikipedia org wiki Domperidonelink springer com article 10 1007 s40261-019-00831-3--- ncbi nlm nih gov pmc articles PMC6800405The European Medicines Agency’s (EMA) pharmacovigilance risk assessment committee (PRAC) after completing the review of domperidone-containing medicines has recommended changes to their use throughout the European Union (EU), which includes using these medicines only to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed test pharmabiz com ema-recommends-restricting-domperidone-use-in-european
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