Risk of serious liver failure with Ulipristal
Risk of serious liver failure with Ulipristal
Risk of serious liver failure with Ulipristal
On 18 February 2021, MHRA issued drug safety update on Ulipristal acetate 5mg (Esmya).
Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb). The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
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.
ulipristal acetate 5mg should no longer be prescribed for controlling symptoms of uterine fibroids while waiting for surgical treatment
Risk of serious liver failure with Ulipristal- Background:
In 2012, Ulipristal acetate 5mg was first authorised for intermittent or pre-operative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age.
The review of Esmya was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation.
The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.
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, further review was conducted, the licences for all ulipristal acetate 5mg medicines were temporarily suspended.
On 18 Mar 2020, Esmya 5mg tablets were recalled from patients, pharmacies and wholesalers in the UK.
To know more Risk of serious liver failure with Ulipristal @ Visit MHRA website.
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