The Health Sciences Authority (HSA) informs healthcare professionals about the temporary suspension of the sales of Esmya (ulipristal acetate) tablet 5 mg, used for the treatment of symptoms of uterine fibroids. The sales of Esmya has been temporarily suspended in Singapore since March 2020 as a precautionary measure, while HSA conducts a reassessment on the benefit-risk profile of Esmya. This was due to ongoing concerns of its association with liver injury, including overseas reports of serious liver injury resulting in liver transplantations that were 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 product. 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 restarted a review in March 2020, to determine if the previous risk minimisation measures were adequate to manage this safety concern.
The EMA’s review was restricted only to ulipristal acetate 5 mg for the treatment of symptoms of uterine fibroids and did not affect the use of ulipristal acetate 30 mg as a single-dose medicine for emergency contraception, as there was no concern about liver injury with the latter. In September 2020, the EMA completed its review of this safety concern, and recommended the revocation of the marketing authorisation of all ulipristal acetate 5 mg products, including Esmya. The EMA’s review took into consideration the reported cases of serious liver injury, as well as the inputs of patient and healthcare professional representatives, including experts in gynaecology. As it was not possible to identify which patients were most at risk of liver injury, or the measures which could reduce this risk, the EMA concluded that the risks of using ulipristal acetate 5 mg for the treatment of symptoms of uterine fibroids outweighed their benefits. Therefore, the EMA recommended that these products should no longer be marketed in the European Union.
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 notification of an overseas case report of serious liver injury with Esmya leading to liver transplantation despite the implementation of risk minimisation measures, HSA has worked with the company to implement the temporary suspension of the sales of Esmya in March 2020 as a precautionary measure, while HSA reassesses the benefit versus risk profile of the product. In the interim, HSA has also issued an advisory for healthcare professionals, including assessing if a switch to alternative therapies was appropriate for their patients, monitoring the liver function of patients who have been prescribed Esmya, and not to start new patients on Esmya.
HSA’s reassessment of the benefit-risk profile of Esmya is currently ongoing, and the review will take into consideration the latest information from overseas developments. HSA will keep healthcare professionals updated on the outcomes of the review when completed.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/temporary-suspension-of-sales-of-esmya-(ulipristal-acetate)-tablet-5-mg-(sep-2020)
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 17 Sept 2020. Letters to inform local healthcare professionals on EMA’s recommendation to suspend ulipristal acetate for uterine fibroids during ongoing review of liver injury 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 has been completed.
As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, September 19, 2020
Issued at HKT 12:00
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