The Health Sciences Authority (HSA) would like to update healthcare professionals on the temporary suspension of the sales of Esmya (ulipristal acetate) Tablet 5mg, used for the treatment of uterine fibroids. 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 (EMA).
In 2018, the EMA had conducted a safety review on the risk of serious liver injury with Esmya, which concluded that there was a risk of rare but serious liver injury with the medicine. As a result, additional measures, such as contraindicating the use of Esmya in patients with underlying liver disorders, more frequent liver function monitoring and restricting the use of multiple courses of the product in women who are not eligible for surgery, were put in place to manage this risk. As a new case of serious liver injury resulting in liver transplantation had occurred despite these measures, the EMA has restarted a review to determine if the previous risk minimisation measures were adequate to manage this safety concern. The EMA’s review is restricted only to ulipristal acetate 5mg for the treatment of uterine fibroids and does not affect the use of ulipristal acetate 30mg as a single-dose medicine for emergency contraception, as there is currently no concern about liver injury with the latter.
Since 2017, HSA has been closely monitoring the overseas reports of rare but serious liver injuries associated with Esmya. In 2018, HSA conducted a benefit-risk assessment on the risk of rare but serious liver injury associated with the use of Esmya in the treatment of uterine fibroids. It was assessed that the benefits of Esmya continue to outweigh the risks of serious liver injury (approximately 1 in 95,000 patients) for its locally approved use, with the implementation of additional risk mitigation measures. These measures include: a) contraindicating the use in patients with underlying liver disorders, b) restricting the use of multiple treatment courses in women who are not eligible for surgical treatment and, c) increasing the frequency of liver function monitoring. These measures were communicated to healthcare professionals via the company’s Dear Healthcare Professional Letter in Apr 2019 and a publication in the Sep 2019 issue of the HSA ADR News Bulletin. A patient information brochure was also developed and disseminated by the company, to advise patients on the potential risk of serious liver injury and the signs and symptoms to look out for, during treatment with Esmya. To-date, HSA has not received any local adverse drug reaction reports of serious liver injury, or liver failure, associated with Esmya treatment in Singapore.
Following the recent overseas case report of serious liver injury with Esmya, HSA is working with the company to implement the temporary suspension of the sales of Esmya as a precautionary measure, while HSA’s reassesses the benefit versus risk profile of the product. In the interim, HSA is recommending the following advisory.
Healthcare professionals are advised:
- to assess the conditions of their patients to determine if a switch to alternative therapies may be appropriate
- to advise patients to monitor for signs and symptoms of liver injury (e.g. yellowing of the skin, fatigue or excessive tiredness, nausea and vomiting), and to contact their doctors immediately if they develop these signs and symptoms
- to monitor the liver function of patients who have been prescribed Esmya, including two to four weeks after stopping treatment
- not to start new patients on Esmya
HSA will take the necessary actions to safeguard public health and keep healthcare professionals updated on the outcome of our review.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/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, the United Kingdom Medicines and Healthcare products Regulatory Agency and HSA, and was posted on the Drug Office website on 14 Mar 2020, 19 Mar 2020 and 27 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, Apr 3, 2020
Issued at HKT 16:00
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