其 他 安 全 警 示
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| Singapore: Esmya (ulipristal acetate) and risk of serious liver injury (English Only) |
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Health Sciences Authority (HSA) announces that Zuellig Pharma Pte Ltd would like to update healthcare professionals on the risk of serious liver injury associated with the use of Esmya (ulipristal acetate). Cases of serious liver injury had been reported overseas in patients treated with Esmya. The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded from its review that Esmya may have contributed to the development of some cases of serious liver injury.
To minimise the risk of serious liver injury associated with the use of Esmya, Zuellig Pharma will be updating the local package insert of Esmya to include warnings on this risk and to inform of the need for liver function monitoring before, during and after treatment with Esmya. The indications for use will also be revised to highlight that Esmya should only be used for the intermittent treatment of moderate to severe symptoms of uterine fibroids, in women of reproductive age who are not eligible for surgical treatment. Esmya continues to be indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../esmya-ulipristalacetateandriskofseriousliverinjury.html
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 12 Jan 2019. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. On 12 Dec 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the relevant warnings should be included in the package insert of the product. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Thursday, Apr 4, 2019
Issued at HKT 15:00
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