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Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk

Published: 19/01/2021

On 18 March 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) suspended the licence for Esmya to protect public health while a safety review is conducted following a further case of liver injury requiring transplant.

The suspension was based on advice from the European Medicines Agency’s safety committee, which has recommended women to stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review is ongoing. No new patients should start treatment with the medicine, which has been temporarily suspended throughout the EU during the review.

The advice for healthcare professionals includes to contact patients currently being treated with Esmya for uterine fibroids as soon as possible, to stop their treatment and consider other treatment options, and to perform liver function testing 2–4 weeks after stopping treatment, as already advised in the product information.

The advice for women includes to stop taking the medicine and contact their healthcare professional for advice on other possible treatments. Women are also advised to consult their healthcare professional if they have questions or concerns about their treatment.