Medicines and Healthcare products Regulatory Agency (MHRA) announces that the indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary suspension has been lifted, this medicine should only be used for intermittent treatment of moderate to severe symptoms of uterine fibroids before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.
In 2018, a European safety review was conducted due to 4 cases reported worldwide of severe liver injury resulting in liver transplantation. Several measures were introduced in 2018 to minimise the risk of severe liver injury.
In 2020, a fifth case of severe liver injury resulting in liver transplantation was reported, prompting a further European review. While this further review was conducted, the licences for all ulipristal acetate 5mg medicines were temporarily suspended. Esmya 5mg tablets were recalled from patients, pharmacies and wholesalers in the United Kingdom on 18 Mar 2020.
The temporary suspension has now been lifted, but the indication for ulipristal acetate 5mg has been further restricted. The review recommended that the risk of severe liver injury does not justify its use for the pre-operative treatment of uterine fibroids. However, the review considered that the benefits of ulipristal acetate 5mg in controlling fibroids may outweigh this risk in women who have no other treatment options. As such, Esmya can be used for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.
The Commission on Human Medicines’ Medicines in Women’s Health Expert Advisory Group (MWHEAG) has considered the safety data and advised that physicians should carefully consider if ulipristal acetate 5mg is an appropriate option for their patient, and accurately and thoroughly discuss the benefits and risks of ulipristal acetate 5mg with them before prescribing. This conversation should include the risk of liver injury and liver failure, including rare cases requiring liver transplantation associated with ulipristal acetate 5mg.
The product information for medicines containing ulipristal acetate 5mg has been amended and a letter sent to healthcare professionals to inform them of the latest safety advice. The prescribing guide for physicians and the patient card will also be updated.
The frequency of occurrence of liver failure with ulipristal acetate 5mg is unknown and no patient risk factors could be identified from the available data. Since authorisation and to date, MHRA has received 20 suspected adverse drug reaction reports of liver disorders with the use of Esmya in the United Kingdom. None report liver transplant or death. In the United Kingdom, Esmya has been suspended since Mar 2020.
The emergency contraceptive ellaOne also contains ulipristal acetate in a single dose of 30mg. No concern has been raised about serious liver injury with ellaOne and there are no changes to its use.
Advice for healthcare professionals:
- Ulipristal acetate 5mg for uterine fibroids has been associated with cases of serious liver injury and liver failure (requiring transplantation in some cases); the licence was temporarily suspended in Mar 2020 to allow a further review of these risks.
- Although the temporary suspension has been lifted, the indication for ulipristal acetate 5mg has been further restricted – it should be used only for intermittent therapy of moderate to severe uterine fibroid symptoms before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or failed.
- Ulipristal acetate 5mg should no longer be prescribed for controlling symptoms of uterine fibroids while waiting for surgical treatment.
- If ulipristal acetate 5mg is felt to be an appropriate therapy, talk about the risks and benefits with patients before prescribing so they can make an informed decision about treatment options; this conversation should include discussion of: all available treatment options for moderate to severe symptoms of uterine fibroids, and the advantages and risks of these depending on personal situation; the potential risk of liver injury and liver failure with ulipristal acetate 5mg, which in rare cases has led to liver transplantation; signs and symptoms of liver injury and what to do if they occur.
- Do not use ulipristal acetate 5mg in patients with an underlying liver disorder.
- Continue to follow advice to monitor liver function according to the recommended schedule of liver function tests before, during, and after treatment courses.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/ulipristal-acetate-5mg-esmya-further-restrictions-due-to-risk-of-serious-liver-injury
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 further 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 14 Nov 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/Friday, Feb 19, 2021
Issued at HKT 17:00
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