其 他 安 全 警 示
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| Canada: Health Canada safety review finds possible link between Fibristal and risk of liver injury (English Only) |
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Health Canada is informing Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury.
Fibristal is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (fibroids) in women of childbearing age.
The department initiated its safety review after receiving four international reports of liver injury leading to liver transplants.
To support the safe use of this medication, Health Canada has worked with the manufacturer to update the Canadian product safety information for Fibristal.
The product safety information updates include new restrictions for use. In particular, Fibristal should not be used in women who currently have, or have previously had liver problems. Intermittent use (more than one treatment course) should be restricted to women of childbearing age who are not eligible for surgery to remove their fibroids. In addition, the product safety information has been updated to include requirements for liver function monitoring before, during and after treatment.
Health Canada will continue to monitor the use of Fibristal and will take action if new safety risks are identified.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../68806a-eng.php
In Hong Kong, Esmya (ulipristal acetate) Tablets 5mg (HK-62553) is a pharmaceutical product registered by Orient Europharma Co. Ltd, and is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Esmya. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2 Dec 2017, with the latest update posted on 11 Sep 2018. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. The safety updates issued by overseas drug regulatory authorities has been discussed by the Registration Committee of the Pharmacy and Poisons Board on 12 Dec 2018 and decided that the relevant warnings should be included in the package insert of the product.
Ends/ Saturday, Jan 12, 2019
Issued at HKT 12:00
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