Other safety alerts
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| Canada: Domperidone Maleate - association with serious abnormal heart rhythms and sudden death (cardiac arrest) |
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The manufacturers of domperidone, in collaboration with Health Canada, would like to inform healthcare professionals that the gastrointestinal motility modifier domperidone should be initiated at the lowest possible dose in adults, including in patients with Parkinson's disease. Recent epidemiological studies have shown that the use of domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death, particularly in patients taking daily doses greater than 30 mg, and in patients older than 60 years of age. Caution should be exercised when using domperidone concomitantly with drugs that prolong the QT interval, in patients who have existing prolongation of cardiac conduction intervals, particularly QTc, and in patients with significant electrolyte disturbances or underlying cardiac disease such as congestive heart failure. The manufacturers of all domperidone products are working with Health Canada to include this new drug dosage and usage recommendations, as well as information about the risk of serious ventricular arrhythmias and sudden cardiac death, in all Canadian Product Monographs for domperidone.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/domperidone_hpc-cps-eng.php
In Hong Kong, there are 53 registered pharmaceutical products containing domperidone. The issue has been discussed in the meeting of The Registration Committee of the Pharmacy and Poisons Board on 28 February 2012. The Committee decided that the sales pack or package insert of domperidone-containing products should be updated to include the appropriate safety information. In view of Health Canada's recommendation, a letter to inform healthcare professionals will be issued.
Ends/ Thursday, March 8, 2012
Issued at HKT 12:30 |
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