Health Canada announces that Allergan Inc. is recalling 7 lots of Fibristal (ulipristal acetate) 5mg Tablet (lot number: T7B236A, T7B231B, T85328B, T85329A, T02566A, T7B231A, T97577T) from wholesalers, healthcare establishments and physicians because during post-market experience, rare cases of liver injury, including cases of serious liver impairment requiring liver transplantation, were reported in patients using ulipristal acetate 5mg.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74051r-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.
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.
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 19 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.
As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Sep 29, 2020
Issued at HKT 15:00
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