In early August 2018 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert to healthcare professionals concerning the risk of serious liver damage from Esmya (ulipristal acetate).
This August 2018 MHRA Esmya alert also provided information about new measures intended to minimize the risk of serious liver damage. These Esmya prescribing restrictions and requirements replace the temporary safety measures introduced in February 2018.
In the US, the FDA has declined to approve Esmya as a treatment for abnormal uterine bleeding in women with uterine fibroids. Instead, the FDA is requesting more information about drug safety issues.