Ulipristal for uterine fibroids should not be marketed in the EU, says EMA
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Ulipristal for uterine fibroids should not be marketed in the EU, says EMA The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids, according to a news item released on 4 September 2020. The recommendation follows a review by EMA’s PRAC, which confirmed that ulipristal acetate 5mg (Esmya and generic medicines) can cause liver injury, including the need for liver transplantation. Ulipristal acetate was authorised for treating moderate-to-severe symptoms of uterine fibroids in women who have not reached menopause for ≤ 3 months before surgery to remove the fibroids, or long-term with treatment breaks in other women. The marketing authorisations of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure on 12 March 2020 while awaiting the outcome of the review. The review considered all available evidence, including case reports of serious liver injury. Representatives of healthcare professionals, including gynaecologists, as well as patients were also consulted. PRAC concluded that the risks of these medicines outweigh their benefits, and these medicines should not be marketed in the EU. PRAC’s recommendation will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP). The recommendation does not affect single-dose ulipristal acetate used for emergency contraception (ellaOne and other trade names), since there is no concern about liver injury in association with these medicines. EMA. PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids. Internet Document : 4 Sep 2020. Available from: URL: https:// www.ema.europa.eu/en/news/prac-recommends-revoking-marketing-authorisation-ulipristal-acetate-uterine-fibroids
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Reactions 12 Sep 2020 No. 1821
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