Risk of cardiac AEs with domperidone: HPRA reminder

Risk of cardiac AEs with domperidone: HPRA reminder Reactions 1664, p2 - 12 Aug 2017 Risk of cardiac AEs with domperidone: HPRA reminder Healthcare professionals are reminded that domperidone is associated with an increased risk of serious cardiac adverse events (AEs), says Ireland’s HPRA in a recent MIMS article. Following concerns raised regarding cardiac AEs associated with the use of domperidone, a European- wide review was initiated in 2014 into the benefits and risks of this drug. The HPRA stated that this review "confirmed that there was a small increased risk of serious cardiac adverse effects associated with the use of domperidone, including QT prolongation, torsades de pointes, ventricular arrhythmia and sudden cardiac arrest". Despite this finding, the review concluded that the benefit-risk profile of domperidone remained positive when used for its restricted indication (i.e. relief of symptoms of nausea and vomiting), and when the risk minimisation measures outlined in the product information were adhered to. The two key areas that these risk minimisation measures apply to are contraindications, and the dose and duration of domperidone use. Specifically, domperidone is contraindicated in the following patient subgroups: those who have known existing prolongation of heart conduction intervals (particularly QT interval prolongation); those with significant electrolyte disturbances or underlying cardiac diseases (e.g. congestive heart failure); those who are receiving concomitant treatment with QT-prolonging medicines, or potent cytochrome P450 (CYP) 3A4 inhibitors (regardless of their QT- prolonging effects); and those who have moderate or severe hepatic impairment. In addition, healthcare professionals should adhere to the dose and duration of use instructions recommended in the Summary of Product Characteristics for domperidone. The drug should be used at the lowest effective dose for the shortest possible duration, but the maximum treatment period should not usually be >1 week. Patients aged > 60 years should consult their doctor before taking domperidone. * HPRA = Health Products Regulatory Authority Health Products Regulatory Authority. Domperidone-containing medicines: Reminder of the risk of cardiac adverse reactions - restricted indication, contraindications and reduced dose and duration of use. Internet Document : [1 page], 26 Jul 2017. Available from: URL: http://www.hpra.ie/docs/default-source/ default-document-library/hpra-mims-article-jul-aug-2017.pdf?sfvrsn=0 803264055 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Risk of cardiac AEs with domperidone: HPRA reminder

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34282-1
Publisher site
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Abstract

Reactions 1664, p2 - 12 Aug 2017 Risk of cardiac AEs with domperidone: HPRA reminder Healthcare professionals are reminded that domperidone is associated with an increased risk of serious cardiac adverse events (AEs), says Ireland’s HPRA in a recent MIMS article. Following concerns raised regarding cardiac AEs associated with the use of domperidone, a European- wide review was initiated in 2014 into the benefits and risks of this drug. The HPRA stated that this review "confirmed that there was a small increased risk of serious cardiac adverse effects associated with the use of domperidone, including QT prolongation, torsades de pointes, ventricular arrhythmia and sudden cardiac arrest". Despite this finding, the review concluded that the benefit-risk profile of domperidone remained positive when used for its restricted indication (i.e. relief of symptoms of nausea and vomiting), and when the risk minimisation measures outlined in the product information were adhered to. The two key areas that these risk minimisation measures apply to are contraindications, and the dose and duration of domperidone use. Specifically, domperidone is contraindicated in the following patient subgroups: those who have known existing prolongation of heart conduction intervals (particularly QT interval prolongation); those with significant electrolyte disturbances or underlying cardiac diseases (e.g. congestive heart failure); those who are receiving concomitant treatment with QT-prolonging medicines, or potent cytochrome P450 (CYP) 3A4 inhibitors (regardless of their QT- prolonging effects); and those who have moderate or severe hepatic impairment. In addition, healthcare professionals should adhere to the dose and duration of use instructions recommended in the Summary of Product Characteristics for domperidone. The drug should be used at the lowest effective dose for the shortest possible duration, but the maximum treatment period should not usually be >1 week. Patients aged > 60 years should consult their doctor before taking domperidone. * HPRA = Health Products Regulatory Authority Health Products Regulatory Authority. Domperidone-containing medicines: Reminder of the risk of cardiac adverse reactions - restricted indication, contraindications and reduced dose and duration of use. Internet Document : [1 page], 26 Jul 2017. Available from: URL: http://www.hpra.ie/docs/default-source/ default-document-library/hpra-mims-article-jul-aug-2017.pdf?sfvrsn=0 803264055 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

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