引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Canada: Summary Safety Review - Fibristal (5 mg ulipristal acetate) - Assessing the potential risk of rare but serious liver injury (English Only) |
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Health Canada announces that it reviewed the potential risk of serious liver injury with Fibristal (5 mg ulipristal acetate) following reports of four international cases of liver injury leading to liver transplantation. In Mar 2018, as an interim measure while the review was ongoing, Health Canada communicated the need to monitor liver function during and after treatment, and recommended not to use Fibristal in patients with liver disease.
Health Canada reviewed 31 reports (7 Canadiana and 24 international) of serious liver injury with Fibristal use. A possible link between liver injury and Fibristal was found in the majority of the cases (20 cases, including 5 Canadian cases). In 6 cases (including 1 Canadian case), the link was found to be unlikely mostly because of the patients' medical condition prior to Fibristal use. In 5 cases (including 1 Canadian case), there was not enough information provided and these could not be assessed. The vast majority of cases recovered or were recovering at the time of reporting (18 of 22 cases for which information was provided). Of the 20 cases having a possible link between Fibristal use and liver injury, 11 cases (2 of which were Canadian cases) reported the use of other medications or medical conditions which may have also contributed to liver injury. No pattern in the timing between Fibristal use and liver injury was found.
There were 4 international cases of liver injury which led to liver transplant. In one case, the outcome was death. The death in this case could not be linked to Fibristal because there was not enough information available. No cases of liver transplant were reported in Canada. A review of the existing published literature did not identify any publications that would raise concerns about liver safety for Fibristal. There was no suggestion of liver injury from earlier research studies (both animal and human data). The mechanism by which Fibristal could potentially cause liver injury is unknown at this time.
Health Canada's review of the available information concluded that there may be a link between the use of Fibristal and serious liver injury. Health Canada is working with the manufacturer to better understand the effects of Fibristal on the liver, and to update the Canadian product information. The updated product information will clarify when to use Fibristal, and recommend monitoring liver function before, during and after stopping treatment.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00210
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 25 Aug 2018. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. In light of the above Health Canada’s announcement, the matter together with the latest safety updates issued by other overseas drug regulatory authorities will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Sep 11, 2018
Issued at HKT 16:00
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