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

  • Kıvanç YükselEmail author
  • Işık Tuğlular
Commentary
  • 22 Downloads

Abstract

European 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 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.

Keywords

Critical review Domperidone EMA decision Restriction Safety 

Notes

Funding

None.

Conflicts of interest

Authors declare that they have no conflict of interest.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Center for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR)Ege UniversityIzmirTurkey

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