Other safety alerts
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| Canada: Association of metoclopramide with neurological adverse events (extrapyramidal symptoms) in the pediatric population |
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Sandoz Canada Inc., Apotex Inc., Omega Laboratories Limited and Pendopharm Division of Pharmascience Inc. in collaboration with Health Canada, informed healthcare professionals and the public of important new safety information regarding the risk of extrapyramidal symptoms in children taking the daily recommended dose of metoclopramide (0.5 mg/kg/day). Metoclopramide is approved in Canada for the treatment of delayed gastric emptying and small bowel intubation.
Extrapyramidal symptoms may occur in children receiving the daily recommended dose of metoclopramide that should not exceed 0.5 mg/kg. Metoclopramide is now contraindicated in children less than one (1) year of age as they appear to be at greater risk of extrapyramidal symptoms. Metoclopramide should not be used in children older than one (1) year unless the anticipated benefits clearly outweigh potential risks.
Health Canada completed a safety review on neurological adverse events in children receiving metoclopramide within the daily recommended dosage of 0.5 mg/kg. The review concluded that a benefit-risk balance was negative in children under one (1) year of age due to safety concerns. Furthermore, it showed that metoclopramide should not be used in children older than one (1) year of age unless the anticipated benefits clearly outweigh potential risks.
The Canadian Product Monographs for metoclopramide drugs were revised recently to include the new contraindication and restrictions on the use of metoclopramide in children.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../43167a-eng.php
In Hong Kong, there are 33 registered pharmaceutical products containing metoclopramide. All of them are prescription-only medicines. Related news had been released by European Medicines Agency and Singapore Health Sciences Authority, and was posted on the Drug Office website on 27 July 2013 and 24 July 2014 respectively. Letter to inform healthcare professionals to draw their attention to the issue and urge them to report any adverse drug reaction related to the drug was issued on 29 July 2013. The matter was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board (the Committee) in September 2014. The Committee decided that the sales pack label and/or package insert of metoclopramide containing products should be updated to include the appropriate safety information. The Department of Health will keep vigilant against any safety updates of the drug.
Ends/ Tuesday, January 06, 2015
Issued at HKT 15:00
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