This alert is to inform you of the restrictions to the use of Esmya for the symptoms of uterine fibroids following completion of an EU review to investigate the link between Esmya and cases of serious liver injury.

Please see the letter attached for actions required:

With immediate effect, Esmya should not be used unless:

• The new restricted indication is met, and the patient does not have an underlying liver disorder; more than one treatment course is now authorised only in women who are not eligible for surgery
• Liver function monitoring is performed before, during and after treatment courses
• The rare risk of liver damage and need for liver function monitoring have been discussed and the patient knows the signs and symptoms of liver injury and what to do if they occur.

Pharmacists should provide the new patient card to women when dispensing Esmya. See letter for how to obtain copies.

These restrictions replace the temporary safety measures, including no new patients to be prescribed Esmya, introduced in February 2018 while the review of the association between Esmya and liver damage was ongoing see - https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102706