Canada: Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids (English Only)
 
Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver. 

The Canadian label for Fibristal was updated in January 2018 to advise Canadians of rare cases of liver injury, including serious liver impairment requiring liver transplants. Since then, additional information on this issue has become available. Health Canada will review all information available at this time, including scientific and medical literature, along with Canadian and international cases of liver injury. The department will continue to update Canadians, including health professionals, as the review is completed. The Department will take action as needed to optimize the benefits of Fibristal and to reduce the risks associated with it. 

Interim information for healthcare professionals are: 
- Before starting patients on Fibristal, evaluate and discuss with them the benefits and risks associated with the medication. 
- Do not prescribe Fibristal treatment if your patient has active/concomitant hepatic disease. 
- Monitor your patient's liver function at least once a month during their Fibristal treatment and 2-4 weeks after completion of treatment. 
- If your patient shows signs or symptoms compatible with liver injury (nausea, vomiting, fatigue, abdominal pain, jaundice), conduct liver function tests on them immediately. 
- Advise your patients about the signs and symptoms of liver injury. 

Please refer to the following website in Health Canada for details: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../66210a-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. 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 9 Mar 2018. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 12 Feb 2018. So far, DH has not received any case of adverse drug reaction related to ulipristal acetate for uterine fibroids. As the review of the drug by European Medicines Agency (EMA) and Health Canada are ongoing, DH will remain vigilant on the conclusion of these reviews and safety update of the drug issued by other overseas drug regulatory authorities. 

Ends/Friday, Mar 16, 2018 
Issued at HKT 16:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/ 
Related Information:
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