View Alert


Originator: MHRA Dear Doctor Letter

From: Dr June Raine, Director, Vigilance and Risk Management of Medicines

Issue date: 07-Aug-2018 10:44:48

This alert has been issued to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • CMO Urgent Messages - Recipients on Public Health Link
  • NHS Trusts (England) - Chief Executive

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health

Action category: Non urgent (cascade within 4 days)

Title: Esmya (ulipristal acetate) for symptoms of uterine fibroids: restrictions to use and requirement to check liver function before, during and after treatment

Broadcast content:

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




Additional information: Please cascade to gynaecology, hepatology, A&E staff, hospital pharmacy and sexual health/family planning centres.

NHS England Regional Offices: please cascade to GP's and Community Pharmacies. Please include the following text in your covering email when sharing with GPs:

"Although this medicine should be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids, we understand some GPs may be asked to issue a repeat prescription"


Alert reference: DDL_Esmya_Aug_2018_Update

Attachments:
Cascade to:
  • #GP#
  • #ACCIDENTEMERGENCY#
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency