Regular liver function testing required during treatment
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Esmya (ulipristal acetate), following reports of serious liver injury. After considering all the evidence, the PRAC concluded that the medicine must not be used in women with liver problems and that certain other patients may start new treatment courses provided they have regular liver tests.
Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb). The medicine has been shown to be effective at reducing bleeding and anaemia, as well as the size of the fibroids.
The PRAC has concluded that Esmya may have contributed to the development of some cases of serious liver injury. The Committee has therefore made the following recommendations to minimise this risk:
- Esmya must not be used in women with known liver problems.
- A liver function test should be performed before starting each treatment course and treatment must not be started if liver enzyme levels are more than 2 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. If the test is abnormal (liver enzyme levels more than 3 times the upper limit of normal), the doctor should stop treatment and closely monitor the patient.
- Esmya should be used for more than one treatment course only in women who are not eligible for surgery. Women who are about to have surgery should continue to use only one course.
- A card will be included in the box of the medicine to inform patients about the need for liver monitoring, and to contact their doctor should they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
- Studies should be performed to determine the effects of Esmya on the liver and whether these measures are effectively minimising the risks.
In February 2018, while the review was ongoing, the PRAC had issued temporary recommendations that no new patients should be started on Esmya. Having finalised its review, the Committee has now concluded that new patients can start treatment in line with the above recommendations to minimise the risk of liver injury.
The PRAC’s recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s final opinion, and this will then go to the European Commission for a final legal decision. A letter will be sent to doctors to inform them of the new restrictions of use, which will become applicable after a Commission decision is issued.