Domperidone safety update

Medicines Safety Update provides practical information and advice on drug safety and information about emerging safety issues. It replaced the Australian Adverse Drug Reactions Bulletin in 2010. Domperidone is a gastrointestinal motility modifier indicated for the short-term treatment of symptoms associated with idiopathic or diabetic gastroparesis in adults, and is also indicated for intractable nausea and vomiting from any cause. The safety alert urges anyone taking domperidone not to stop taking the drug or change the dose before consulting with their doctors, and to ask their health-care providers if they have been given. In line with this recommendation, sections 4.3, 4.4 and 4.5 of the SmPC for all domperidone containing products should be updated to reflect, that domperidone, as an ex ception, may be co-administered Domperidone is a dopamine antagonist with antiemetic properties. A European review assessed the benefits and risks of domperidone following continued reports of cardiac side effects. The review. Domperidone is a dopamine antagonist with antiemetic properties. It should no longer be sold to anyone without a prescription. It is associated with a small increased risk of serious cardiac side. Drug Safety. 33(11): 1003-14. Johannes CB, Varas-Lorenzo C, McQuay LJ, et al. 2010. Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study. A European medicines regulatory body (CMDh) has endorsed recommendations from the European Medicines Agency (EMA) to restrict the use of medications containing domperidone. Domperidone containing products have authorised nationally been in several EU member states since the 1970s and have been available in the United Kingdom under the trade name Motilium and as the generic, domperidone. List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) Related Information: Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs including requirements for PSURs submission.

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