Risk of serious liver injury with Esmya
The EMA’s PRAC has issued new recommendations on the use of Esmya (ulipristal acetate) following a review of its effects on the liver. Esmya is indicated for the treatment of moderate to severe symptoms of uterine fibroids, to reduce bleeding, anaemia and fibroid size. Esmya is taken as a treatment course comprising one 5mg tablet daily for up to three months.
The PRAC concluded that in rare cases, Esmya may contribute to the development of serious liver injury. About eight cases of serious liver injury in which Esmya could have contributed a role have been recorded, out of a total of approximately 765,000 patients treated. The PRAC has therefore recommended that Esmya must not be used in women with liver problems. In addition, a liver function test should be performed before starting each treatment course and treatment should not be initiated if liver enzymes are more than two times the upper limit of normal. Liver function tests should be performed once a month during the first two treatment courses and two to four weeks after stopping treatment. Treatment should be stopped and the patient closely monitored if liver enzymes are more than three times the upper limit of normal.
The PRAC adds that Esmya should be used for one treatment course only, except in the case of women who are not eligible for surgery. A card will be included in the packaging to inform patients to contact their doctor if they develop symptoms of liver injury. Symptoms may include tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting.
No cases of serious liver injury have been reported with the emergency contraceptive ellaOne, which also contains ulipristal acetate administered as a single dose, and the PRAC recommendations therefore do not extend to the use of ellaOne.