PRAC Recommends Regular Liver Testing for Women Taking Esmya

Troy Brown, RN

February 09, 2018

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) recommended liver function testing at least monthly for women taking ulipristal acetate (Esmya, Gedeon Richter) for uterine fibroids while a review of the harms and benefits of the drug is underway.

The recommendation comes after reports that four women taking the drug experienced serious liver damage; three of these women required liver transplants. The EMA announced a review of ulipristal acetate on December 1, 2017.

The EMA also recommends immediate measurement of transaminase levels for women who experience signs and symptoms consistent with liver damage, including nausea, vomiting, right hypochondrial pain, anorexia, asthenia, and jaundice. Clinicians should discontinue treatment with ulipristal acetate in women whose transaminase levels are more than twice the upper limit of normal and should monitor them closely, repeating liver function testing 2 to 4 weeks after stopping treatment.

Clinicians should not start any new patients on the drug and not begin additional courses of treatment in those who have already completed a course of treatment while the review is ongoing. Clinicians should counsel their patients about the signs and symptoms of liver damage.

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 for as long as 3 months before surgical fibroid removal in some women; other women take the drug in repeated courses with time off between courses.

The US Food and Drug Administration has not approved ulipristal acetate for treatment of uterine fibroids, but the drug is approved for use in a single dose as emergency contraception. It is authorized for both indications in the European Union. There are no reports of liver damage in women who have taken ulipristal acetate as an emergency contraceptive.

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