The European Medicines Agency (EMA) has started a review of Allergan’s Esmya, a drug used to treat uterine fibroids, following reports of serious liver injuries.
The review comes after four reports of serious liver injury, three of which ended in liver transplants, in patients treated with the drug. The EMA's Pharmacovigilance Risk Assessment Committee will investigate whether there is a causal link between Esmya and liver damage.
Esmya, which is still awaiting approval from the U.S. FDA, was approved in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids.
Read the EMA statement