Esmya (ulipristal acetate) for uterine fibroids – CAS alert

13 Feb 2018

An alert has been issued by the Central Alerting System (CAS) regarding liver injury and the use of Esmya (ulipristal acetate) for uterine fibroids

A Central Alerting System (CAS) alert has been issued regarding Esmya (ulipristal acetate) tablets 5mg. Temporary safety measures have been introduced following reports of serious liver injury in women of reproductive age being treated with Esmya tablets for uterine fibroids. The alert states that:

 

  • Current and recent patients treated with Esmya tablets should have their liver function monitored
    • At least once a month for patients currently taking Esmya tablets
    • Two to four weeks after stopping treatment for recently treated patients
  • Treatment should not be initiated in new patients, or those between treatment courses
  • Healthcare professionals should be aware of patients presenting with signs or symptoms associated with liver injury, such as nausea and vomiting
    • Patients taking Esmya tablets should also be advised on the signs and symptoms

 

EllaOne tablets 30mg also contain ulipristal acetate; however no cases of serious liver injury have been reported, and currently there are no concerns with this medicine.

Further information can be found on the CAS website.

 

For further information on this or any other query, please contact the NPA Pharmacy team on 01727 891 800 or email pharmacyservices@npa.co.uk.

 

Produced by the NPA Pharmacy team February 2018.