The Health Sciences Authority (HSA) announces that Zuellig Pharma Pte Ltd, the product registrant of Esmya (ulipristal acetate) Tablet 5mg, will be voluntarily withdrawing the product from the Singapore market. This is due to concerns with overseas cases of serious liver injury requiring liver transplantation and that it is not possible to identify which patients are most at risk for developing liver injury or to identify measures that could further reduce the risk.
Esmya has been registered for use in Singapore since November 2014, for the pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age. In March 2020, HSA had temporarily suspended the sales of Esmya in Singapore as a precautionary measure, due to ongoing concerns of its association with liver injuries reported overseas.
The withdrawal does not affect Ella (ulipristal acetate) Tablet 30mg (Hyphens Pharma Pte Ltd) registered for use as an emergency contraception, as there is no concern about liver injury with this product.
Since 2017, HSA had been monitoring the safety concern of liver injury with Esmya, following overseas reports of serious liver injuries which had resulted in liver transplantation. HSA conducted a benefit-risk assessment and implemented additional risk mitigation measures in 2018 to minimise the risk of liver injuries in patients taking Esmya. These measures included prohibiting its use in patients with underlying liver disorders, restricting the use of multiple treatment courses in women who are not eligible for surgery, and increasing the frequency of liver function monitoring. The measures were communicated to healthcare professionals in April 2019 via the company’s Dear Healthcare Professional Letter and published in the September 2019 issue of the HSA ADR News Bulletin.
In March 2020, following the report of another overseas case report of serious liver injury with Esmya requiring liver transplantation, HSA temporarily suspended the sales of Esmya in Singapore as a precautionary measure, while it continued its reassessment of the benefit-risk profile of Esmya for the local population. A Dear Healthcare Professional Letter was issued for healthcare professionals to review the use of the medicine in their patients and to decide whether a switch to alternative therapies may be appropriate. Healthcare professionals were also advised not to start new patients on Esmya and to monitor existing patients for liver injury for two to four weeks after stopping treatment. To date, HSA has not received any local reports of serious liver injury related to treatment with Esmya.
The local sales of Esmya has been suspended since March 2020. Healthcare professionals are advised to contact patients under their care who may still be treated with Esmya to:
- Stop Esmya and review alternative treatment options
- Monitor the liver function of these patients two to four weeks after stopping Esmya treatment
- Advise patients to monitor for signs and symptoms of liver injury (e.g. dark-coloured urine, yellowing of the skin, excessive tiredness, nausea and vomiting), and to contact their doctors immediately if they develop these signs and symptoms.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/voluntary-withdrawal-of-esmya-(ulipristal-acetate)-tablet-5mg-by-zuellig-pharma-pte-ltd
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 05 Oct 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/Saturday, Oct 10, 2020
Issued at HKT 11:00
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