Other safety alerts
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| Australia: Medicines Safety Update: Metoclopramide and neurological adverse events |
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The TGA has recently completed an analysis of the findings of a European Medicines Agency (EMA) review of metoclopramide which is a widely used antiemetic and gastroprokinetic drug. In December 2013, the European Commission adopted the EMA's recommended changes to restrict the dose and duration of use of metoclopramide to reduce the risk of potentially serious neurological adverse events, including extrapyramidal disorders and tardive dyskinesia, as well as rare cardiac conduction disorders. The TGA has worked closely with the sponsor to update the Product Information (PI) for prescription metoclopramide products to include information about the risk of neurological adverse events.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6-number-1-february-2015#metoclopramide
In Hong Kong, there are 33 registered pharmaceutical products containing metoclopramide. All of them are prescription-only medicines. Related news has been released by EMA, Singapore HSA and Health Canada, and was posted on the Drug Office website on 27 July 2013, 24 July 2014 and 6 January 2015 respectively. Letters 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. As previously reported, 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. So far, the Department of Health (DH) has not received any adverse reaction report related to the drug. The DH will keep vigilant on the safety updates of the drug.
Ends/ Monday, February 02, 2015
Issued at HKT 18:00
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