EMA review of Esmya, a treatment for uterine fibroids requires no new patients to be started on Esmya.-Gedeon Richter + Allergan

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya from Gedeon Richter + Allergan, following reports of serious liver injury, including liver failure leading to transplantation. As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids. All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient.

Liver tests should be repeated 2 to 4 weeks after stopping treatment. The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being. A link between Esmya and cases of serious liver injury is under review.

. Comment: A spokesman from Allergan said in December, that no cases of liver transplantation occurred in any of the controlled clinical trials for Esmya in the EU, Canada or the U.S.