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Regulatory News | 09 February 2018 | By Michael Mezher
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) on Friday recommended that women taking Gedeon Richter's Esmya (ulipristal) to treat uterine fibroids undergo regular liver testing while the agency investigates reports of liver failure related to the drug.
PRAC also recommended that no new patients begin taking Esmya, and that patients who have already completed a course of the drug wait until the agency has completed its safety review before beginning a new course.
"All women taking Esmya should have a liver function test at least once a month during treatment," EMA writes, adding that if liver enzyme levels are more than twice the upper limit for normal levels the patient's physician should discontinue treatment immediately and monitor the patient.
EMA is also advising patients to be on the lookout for signs of liver injury, including nausea, vomiting, stomach pain, lack of appetite or yellowing of the eyes or skin while taking the drug.
EMA first launched its safety review into Esmya in December 2017 after PRAC concluded that the reports of liver injury could be caused by the drug, which was first authorized in the EU in 2012. The drug is also marketed by Allergan as Fibristal in Canada, and in October 2017, Allergan announced the US Food and Drug Administration (FDA) had accepted its new drug application (NDA) for the drug for review.
Following news of EMA's safety review in December, Gedeon Richter denied a link between the drug and liver damage. At the time, a spokesperson for the company Zsuzsa Beke told Reuters that "we consider that there is no demonstrable link between liver damage and treatment with Esmya."