Critical review of European Medicines Agency (EMA) assessment report and related literature on domperidone

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dc.contributor.authorYuksel, Kivanc
dc.contributor.authorTuglular, Isik
dc.date.accessioned2019-10-27T09:44:59Z
dc.date.available2019-10-27T09:44:59Z
dc.date.issued2019
dc.departmentEge Üniversitesien_US
dc.description.abstractEuropean Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30mg and treatment duration to 7days. 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 observational studies used by EMA were published, the EMA didn't use an algorithm including randomized clinical trials according to evidence-based medicine when presenting their results. In conclusion, the results obtained from published studies are controversial, especially for the bias. From these publications, it cannot be concluded that domperidone exposure definitely increases the risk of sudden cardiac death, death associated with ventricular arrhythmia or ventricular arrhythmia The most concrete result of these studies is that the risk is higher with metoclopramide exposure compared to domperidone exposure.en_US
dc.identifier.doi10.1007/s11096-019-00803-9en_US
dc.identifier.endpage390en_US
dc.identifier.issn2210-7703
dc.identifier.issn2210-7711
dc.identifier.issue2en_US
dc.identifier.pmid30864085en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage387en_US
dc.identifier.urihttps://doi.org/10.1007/s11096-019-00803-9
dc.identifier.urihttps://hdl.handle.net/11454/29077
dc.identifier.volume41en_US
dc.identifier.wosWOS:000467578900002en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.relation.ispartofInternational Journal of Clinical Pharmacyen_US
dc.relation.publicationcategoryDiğeren_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectCritical reviewen_US
dc.subjectDomperidoneen_US
dc.subjectEMA decisionen_US
dc.subjectRestrictionen_US
dc.subjectSafetyen_US
dc.titleCritical review of European Medicines Agency (EMA) assessment report and related literature on domperidoneen_US
dc.typeEditorialen_US

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