其 他 安 全 警 示
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| European Union: PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids (English only) |
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A review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therefore recommended the revocation of the marketing authorisations of these medicines.
The PRAC considered all the available evidence in its review, including reported cases of serious liver injury. Patient and healthcare professional representatives, including experts in gynaecology, were also consulted. Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU.
The use of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review.
The PRAC recommendation will now be forwarded to EMA’s human medicines committee (CHMP), which will adopt the Agency’s opinion.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/prac-recommends-revoking-marketing-authorisation-ulipristal-acetate-uterine-fibroids
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 14 April 2020. Letters to inform local healthcare professionals on EMA’s recommendation to suspend ulipristal acetate for uterine fibroids during ongoing review of liver injury 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 has been completed.
In light of the above EMA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, Sept 5, 2020
Issued at HKT 12:30
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