Be aware of rare but possible risk of liver injury in medical treatment of fibroids

15 February 2018

The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

Esmya (ulipristal) is used for the treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age. The treatment is effected only by specialised physicians in gynaecology.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee, PRAC, has initiated an extraordinary review to establish if there is a link between Esmya (ulipristal) and the risk of developing serious liver injury. The assessment by PRAC will be based on a thorough review of data and scientific assessments and is expected to be completed by May 2018. Until then, the recommendation is that no new patients should be started on Esmya. Please read the European Medicines Agency's press release with recommendations in respect of Esmya here.

The PRAC has initiated the review because of reports of five patients throughout Europe who developed serious liver injury after treatment with Esmya. Some of the affected patients have previously had liver problems or have taken other types of medicines, which makes it uncertain to what degree Esmya has anything to do with the liver injuries.

At this point, the Danish Medicines Agency has not received any ADR reports describing liver effects with the use of Esmya. But we concur with the PRAC recommendation that no new patients should be started on Esmya.

Information for patients

If you are taking Esmya and experience any signs of impaired liver function, you should contact your doctor immediately. Signs of impaired liver function could be nausea, vomiting, lack of appetite, upper or right belly pain, yellowing skin or eyes, or itching. If you have any of these symptoms, you should stop the treatment immediately and not resume treatment until you have consulted a doctor. 

Information for doctors

Ulipristal acetate is indicated for pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Gynaecologists should not start new patients on Esmya. This applies also to patients who receive intermittent courses, implying they should not be started on a new treatment course. The Danish Medicines Agency encourages the treating doctors to contact their patients.

Patients who are taking Esmya should have a liver function test every month as well as two to four weeks after stopping treatment.

If a patient’s liver function is suspected to be impaired or affected, treatment with Esmya should be stopped immediately, and alternatives should be considered.

The company has sent out letters to doctors by post. 

Further information

The Danish Medicines Agency will provide an update here on the website once the PRAC review has been completed.

Esmya has been available for treatment of patients since 2012. It is estimated that about 670,000 women have been treated with Esmya in Europe. In Denmark, a total of 534 patients have redeemed at least one prescription for Esmya.

Ulipristal is also the active ingredient in the emergency contraception EllaOne (morning-after pills). No serious liver injuries have been reported for this product, and no concerns have been raised about the product. 

For more information about the case, we refer to the website of the European Medicines Agency.

Doctors and patients are encouraged to report all suspected side effects on the website meldenbivirkning.dk (report a side effect).

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