EMA recommends temporary suspension and recall of uterine fibroids medicine ulipristal acetate 5mg

News Category: Regulatory news

Date: 13/03/2020

Ongoing EMA review indicates risk of serious liver injury 

The European Medicines Agency (EMA) has recommended, as a precautionary measure, that women should stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review on the risk of serious liver injury is ongoing.

The EMA is starting its review following a recent case of liver injury, which led to liver transplantation in a patient taking the medicine. Cases of serious liver injury have been reported, including 5 that led to transplantation, out of over 900,000 patients who have been treated with ulipristal acetate for fibroids since its authorisation in 2012. A 2018 EMA review concluded that there is a risk of rare but serious liver injury with ulipristal acetate medicines for the treatment of uterine fibroids, and measures were implemented to minimise the risk. However, as the new case of serious liver injury occurred in spite of adherence to these measures, the EMA has started a new review.

To protect patients’ health, the EMA is recommending the temporary suspension of the medicine ‘s marketing authorisation in the EU and a recall of batches from pharmacies and patients while the safety review is completed.

Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This review does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines.

Further information, including advice for patients and healthcare professionals, is available from the EMA’s website.

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