Safety Alerts
Voluntary withdrawal of Esmya™ (ulipristal acetate) Tablet 5mg by Zuellig Pharma Pte Ltd
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
9 October 2020
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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.
Background on the safety concern of liver injuries1-4
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™.
HSA’s advisory
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.
Zuellig Pharma Pte Ltd will be sending a letter to inform healthcare professionals and its purchasers, of the company’s decision to withdraw the product registration of Esmya™ in Singapore.
References