Other safety alerts
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| Singapore: Domperidone and risk of cardiac arrhythmia and sudden cardiac death |
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Recently, two epidemiological studies describing possible association of risk of serious ventricular arrhythmia (SVA) and sudden cardiac death (SCD) with oral domperidone had been published. It was concluded from the studies that there are some evidence that domperidone may be associated with an increased risk of SVA or SCD when oral domperidone is used at higher doses (>30mg/day), or in patients >60 years old. HSA is currently working with relevant product licence holders to update the package inserts of local domperidone products to reflect the current information on the risk of SVA and SCD associated with the use of the product. Health care professionals should be aware of these risks and be cautious, particularly when treating high risk patients with domperidone. When supplying domperidone as a POM with exemptions for supply without prescription, pharmacists are advised to check their patient's medical history and avoid dispensing domperidone to patients with underlying cardiac disorders. They may wish to advise patients with underlying cardiac disorders to consider alternative medicines or to seek advice from their doctors on the suitability of domperidone.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/product_safety_alerts/Safety_Alerts_2012/domperidone_and_risk.html
In Hong Kong, there are 52 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. The related safety news was released by Health Canada and was posted on the website of Drug Office on 8 March 2012. A letter to inform healthcare professionals was also issued on the same day.
Ends/ Saturday, April 21, 2012
Issued at HKT 15:00
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