Doctors are not to prescribe Gedeon Richter and Allergan’s Esmya for uterine fibroids in the UK while European regulators carry out a safety review of the drug.
The European Medicines Agency started a review of Esmya (ulipristal acetate) for uterine fibroids in December following reports of four cases of serious liver injury after its use, leading to liver transplants in three of the cases.
Temporary safety measures have now been introduced advising that no new treatment courses with the drug should be initiated while the review is ongoing, and that those already taking it have blood tests to monitor their liver function at least once a month.
If the test is abnormal, showing liver enzyme levels more than two times the upper limit of normal, the healthcare professional should stop treatment and closely monitor the patient, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has stressed.
Esmya was first approved in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids - non-cancerous (benign) tumours of the womb - in women who have not reached the menopause.
While Gedeon Richter markets the drug in Europe, Allergan markets it under the name Fibristal in Canada.