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

European 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.