EMA Safety Panel Recommends Revoking Esmya Market Authorization for Uterine Fibroids

The EMA’s Pharmacovigilance Risk Assessment Committee has recommended revoking the market authorization for Esyma (ulipristal acetate) for uterine fibrosis because of the risk of liver injury.

The expert committee found that the risks of the drug outweighed its benefits and said it was not possible to know which patients are most at risk for liver injury or how to reduce the risk.

The panel said there is no concern about the risk of liver injury for single-dose ulipristal acetate, which is used for emergency contraception.