Uterine fibroids

EMA recommends restricting the use of ulipristal for uterine fibroids

The European Medicines Agency (EMA) has recommended that the use of ulipristal be restricted as a result of cases of serious liver injury.[83]European Medicines Agency. Ulipristal acetate for uterine fibroids: EMA recommends restricting use. 13 November 2020 [internet publication]. https://www.ema.europa.eu/en/medicines/human/referrals/ulipristal-acetate-5mg-medicinal-products

Previously, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended revoking the drug’s marketing authorization for this indication in Europe.[84]European Medicines Agency. PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids. Sept 2020 [internet publication]. https://www.ema.europa.eu/en/news/prac-recommends-revoking-marketing-authorisation-ulipristal-acetate-uterine-fibroids But, after careful consideration, they have confirmed the benefits of ulipristal in controlling uterine fibroids might outweigh this risk in women who have no other treatment options. Therefore, they now recommend that ulipristal remains available to treat premenopausal women who cannot have surgery (or for whom surgery had not worked). Ulipristal must not be used for controlling uterine fibroids in women who are awaiting surgical treatment.

In 2018, the EMA reviewed the benefits and risks of ulipristal for the treatment of uterine fibroids following reports of serious liver injury, including liver failure leading to transplantation and measures were implemented to minimize the risk.[85]European Medicines Agency. Esmya: new measures to minimise risk of rare but serious liver injury. 31 May 2018 [internet publication]. https://www.ema.europa.eu/en/medicines/human/referrals/esmya However, as these cases were followed by another case of severe liver damage resulting in liver transplantation, despite adherence to measures to minimize the risk, the EMA started a new safety review in early 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) also issued a drug safety update for ulipristal that provided similar advice.[87]Medicines and Healthcare products Regulatory Agency. Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury. 18 March 2020 [internet publication]. https://www.gov.uk/drug-safety-update/esmya-ulipristal-acetate-suspension-of-the-licence-due-to-risk-of-serious-liver-injury

Ulipristal is approved as a single-dose medication for emergency contraception in some countries; these restrictions do not apply to this indication.

See Management: emerging

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