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Domperidone is a specific blocker of dopamine receptors It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms Mechanism of action Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant European Commission to take final legal decision The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed recommendations to restrict the use of domperidone-containing medicines --- hpra ie docs default-source hpra-imf-article-august-2017 pdfgo drugbank com drugs DB01184Overview 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 link springer com article 10 1007 s11096-019-00803-9Domperidone is a dopamine D2 receptor antagonist acting on the chemoreceptor trigger zone in the medulla and also in the gut, causing antiemetic and gastrokinetic effects respectively In the past, domperidone was considered largely safe, with many indications and few contraindications listed in the product literature In 2014, Domperidone became indicated only for the prevention of nausea and --- ncbi nlm nih gov pmc articles PMC6800405--- ema europa eu en medicines human domperidone-containing-medicines--- ncbi nlm nih gov pmc articles PMC4418779--- ema europa eu cmdh-confirms-recommendations-restricting-use-domperido treatment with domperidone should be reassessed at a routine appointment to advise on treatment continuation, dose change, or cessation iii In 2014 a European-wide review recommended restrictions on the use of domperidone-containing medicines following an evaluation of the benefits and risks of domperidone ThisEuropean Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30 mg and treatment duration to 7 days This paper presents a critical review of the scientific basis of the literatures having a role in the decision of EMA on domperidone with an approach based on statistical and epidemiological perspective Although europepmc org article MED 17488253bmjopenquality bmj com content 5 1 u209711 w4039Based on a handful of European clinical trials, questions were raised in the past concerning domperidone's potential to cause QTc prolongation with increased potential for ventricular arrhythmias A nested case-control study from the Netherlands 5 reported an increased risk of 44% for serious ventricular arrhythmias (SVA) and SCD with a domperidone dosage of 40 mg d orally compared with proton 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 Domperidone is a dopamine-2 receptor antagonist It acts as an antiemetic and a prokinetic agent through its effects on the chemoreceptor trigger zone and motor function of the stomach and small intestine Unlike metoclopramide, it does not cause any adverse neurological symptoms as it has minimal penetration through the blood-brain barrier
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