其 他 安 全 警 示
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| Singapore: Temporary suspension of the sales of Esmya (ulipristal acetate) Tablet 5mg (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Zuellig Pharma Pte Ltd to update healthcare professionals on the temporary suspension of the sales of Esmya (ulipristal acetate) Tablet 5mg. This is due to ongoing concerns of its association with liver injuries, the most recent of which involved an overseas report of serious liver injury resulting in liver transplantation that was surfaced by the European Medicines Agency. The temporary suspension is implemented as a precautionary measure while HSA reassesses the benefit-risk profile of Esmya.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/temporary-suspension-of-the-sales-of-esmya-(ulipristal-acetate)-tablet-5mg
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 the European Medicines Agency and the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 14 Mar 2020 and 19 Mar 2020. Letters to inform local healthcare professionals 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 DH will continue to monitor the recall.
The DH will remain vigilant on the conclusion of the review and safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Mar 27, 2020
Issued at HKT 15:00
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