PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

This recommendation is based on evidence which confirms that 5mg ulipristal acetate for treatment of symptoms of uterine fibroids can cause liver injury, including liver transplantation. It is not known which patients are most at risk or what measures could reduce risk.

SPS commentary:

This recommendation 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.


European Medicines Agency