(Reuters) - European Medicines Agency issued guidelines on Friday to help minimize the risk of rare but serious liver injury associated with Hungarian drugmaker Richter’s Esmya.
The regulator opened a review of Esmya, which is used to treat benign tumors of the womb, in late-November after reports of serious liver damage in patients treated with the drug.
The review found that the drug may have contributed to some cases of serious liver damage, European health regulators said last month.
EMA on Friday recommended women with known liver problems should not use the drug and conduct liver tests before, during and after stopping treatment.
Use of the medicine for more than one treatment course be been restricted to women who are not eligible for surgery, the regulator said.
Richter, which has partnered with Allergan in the United States, has said it considered Esmya to be a safe and effective form of treatment.
Reporting by Arathy S Nair in Bengaluru; Editing by Sriraj Kalluvila