Health Canada announces that rare cases of liver injury, including cases of serious liver impairment requiring liver transplantation, have been reported internationally in patients using ulipristal acetate tablets, 5 mg. It has been determined that it is not possible to identify which patients are most at risk for developing liver injury, or identify measures that could further reduce the risk. No cases of serious liver impairment leading to transplantation have been reported in Canada.
Health Canada conducted a safety review of FIBRISTAL and concluded that there may be a link between its use and risk of serious liver injury. On 11 Jan 2019, Health Canada informed Canadians of this risk. To address this safety concern, Health Canada worked with Allergan Inc. to update the Canadian Product Monograph for FIBRISTAL and implement safety measures. The company was also directed to conduct specific studies to look at the effectiveness of these new safety measures.
On 16 Sep 2020, Health Canada announced that it was again reviewing the risk of serious liver injury associated with FIBRISTAL. This review was in response to a recent international case of liver injury requiring liver transplantation, and the European Medicines Agency Pharmacovigilance Risk Assessment Committee’s recommendation to revoke the marketing authorization of the ulipristal acetate medication called ESMYA in Europe.
On 24 Sep 2020, Allergan Inc. initiated the recall of FIBRISTAL from the Canadian market due to serious drug-induced liver injury (DILI), including rare international cases of severe liver injury requiring liver transplant.
Due to serious DILI, including rare international cases of severe liver injury requiring liver transplant, FIBRISTAL will be removed from pharmacies across Canada after the manufacturer decided to voluntarily withdraw FIBRISTAL from the Canadian market.
Healthcare professionals are advised to:
- Not prescribe or dispense FIBRISTAL prescriptions.
- Contact patients under their care who are currently being treated with FIBRISTAL to stop FIBRISTAL and review alternative treatment options; and advise patients to immediately report symptoms of liver injury, which could occur after stopping treatment, such as nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine.
- Perform liver function monitoring within 2-4 weeks after treatment with FIBRISTAL has stopped and investigate further if liver function is abnormal.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74063a-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 on the previous review of Esmya 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 13 Sep 2019. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. In Dec 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of the product should include the relevant safety information.
Related news on the recent review of Esmya was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 14 Mar 2020, with the latest update posted on 29 Sep 2020. Letters to inform local healthcare professionals of the European Medicines Agency’s recommendation to suspend ulipristal acetate for uterine fibroids were issued by the DH on 16 Mar 2020.
On 20 Mar 2020, the DH endorsed Orient Europharma Co. Ltd to voluntarily recall Esmya Tablets 5mg (HK-62553) from patients due to the potential risk of liver injury. The recall was completed.
As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, Oct 5, 2020
Issued at HKT 15:00
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