European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended, as a precautionary measure, that women should stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review started this month is ongoing. No new patients should start treatment with these medicines, says the EMA.
The start of the review follows a recent case of liver injury, which led to liver transplantation in a patient taking the medicine.
A 2018 PRAC review concluded that there is a risk of rare but serious liver injury with ulipristal acetate medicines for uterine fibroids and measures were implemented to minimise the risk. However, as the new case of serious liver injury occurred despite adherence to these measures, the committee has started a new review.
Cases of serious liver injury have been reported, including five that led to transplantation out of over 900,000 patients who have been treated with ulipristal acetate for fibroids since its authorisation in 2012.
Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. The EMA emphasises that 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.
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