![]() ![]() Serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously been evaluated by the EMA and the product information updated with relevant warnings. The injectable form of domperidone was withdrawn in 1985 because of such side effects. The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart. ![]() The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee ( PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.ĭomperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn. The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms of nausea and vomiting, that doses and length of treatment should be restricted and that they should be adjusted carefully by the patient's weight where available for use in children. 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.
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