EMA recommends restricting use of ulipristal: risk of liver injury
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EMA recommends restricting use of ulipristal: risk of liver injury The human medicines committee (CHMP) of the European Medicines Agency (EMA) has recommended restricting use of ulipristal acetate 5mg [Esmya and generic products] to the treatment of uterine fibroids in premenopausal women in whom surgical procedures (including embolisation) are not appropriate or have failed. Ulipristal 5mg should not be used for the control of symptoms in patients with uterine fibroids who are waiting for surgical treatment. The CHMP made this recommendation after the EMA’s safety committee (PRAC) reviewed cases of serious liver injury and liver failure in patients receiving ulipristal 5mg. Information on the risk of liver failure, leading to liver transplantation in some cases, will be added to the summary of product characteristics and the package leaflets for ulipristal 5mg. The PRAC found that it was not possible to identify patients at risk of ulipristal-related liver injury, or measures that could reduce the risk, and therefore advised that ulipristal medicines should not be marketed in the EU. Although the CHMP endorsed this risk assessment, it considered that the benefits of ulipristal 5mg in controlling fibroids may outweigh its risks in women with no other treatment options. The CHMP’s recommendation will now be forwarded to the European Commission for a decision. The use of ulipristal 5mg for uterine fibroids has been suspended as a precaution until its decision is made. This recommendation does not affect the use of ulipristal [ellaOne] as a single-dose medicine for emergency contraception. Healthcare professionals are advised to monitor patients receiving ulipristil 5mg for signs and symptoms of liver damage, and patient are advised to stop treatment and contact their doctor immediately if they develop signs of liver injury. EMA. Ulipristal acetate for uterine fibroids: EMA recommends restricting use. Internet Document : 13 Nov 2020. Available from: URL: https://www.ema.europa.eu/en/news/ 803518256 ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use
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Reactions 28 Nov 2020 No. 1832
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