The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended revoking marketing authorization of ulipristal acetate (Esmya, Gedeon Richter, and generic medicines) for uterine fibroids after an evidence review confirmed the risk of liver injury.
Ulipristal acetate reduces the size of uterine fibroids in women who have not yet started menopause by blocking the effects of progesterone. It is used by some women for as long as 3 months before surgical fibroid removal; other women take the drug in repeated courses, with time off between courses.
In February 2018, the EMA concluded that there is a risk for rare but serious liver injury with ulipristal acetate for the treatment of uterine fibroids, and recommended liver function tests at least monthly in women taking the drug, as reported by Medscape Medical News.
In March of this year, PRAC recommended women stop using 5-mg ulipristal acetate for uterine fibroids pending a thorough review of liver injury risk.
The EMA on Friday said PRAC’s review has confirmed that 5-mg ulipristal acetate can cause liver injury, including the need for a liver transplant, prompting a recommendation to revoke authorization for this indication in Europe, according to a news release.
“Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU,” the EMA said.
Ulipristal acetate is also approved in Europe (and in the United States) for use as a single dose for emergency contraception. Today’s 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, the EMA said.
The PRAC recommendation will now be forwarded to the EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the agency’s opinion.