202003 MHRA Esmya

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From: safetyalerts@mhra.gov.uk <safetyalerts@mhra.gov.uk>
Sent: 18 March 2020 11:09
Subject: Central Alerting System: Class 2 Drug Alert, Action Within 48 Hours, Patient Level Recall, Gedeon Richter (Uk) Ltd, Esmya 5mg Tablets (Ulipristal Acetate)



Cascade codes: #COMMUNITYPHARMACISTS#, #DISPENSING GP#, #GP#, #HospitalPharmacy#
Category: Class 2: Action within 48 hours
Issue date: 18-Mar-2020
Reference: EL (20)A/16
From: Himal Makwana
Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) – Medical Director
  • NHS Trusts (England) – Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
For information to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) – Chief Executive
  • Social Care Providers (registered with CAS)
  • MHRA (Medicines) Drug Alerts – Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) – Chief Executive
  • GP – Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Primary Care Networks
Title: Class 2 Drug Alert, Action Within 48 Hours, Patient Level Recall, Gedeon Richter (Uk) Ltd, Esmya 5mg Tablets (Ulipristal Acetate)


Gedeon Richter (UK) Ltd is recalling all unexpired stock of the above products from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine. To protect patients while a safety review is conducted, the European Medicines Agency?s safety committee, Pharmacovigilance Risk Assessment Committee, (PRAC) has recommended that women stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids.


Contact patients who have been supplied Esmya and ask them to stop taking their medication as soon as possible and return any unused medicine to their pharmacy. All patients currently being treated with Esmya/ulipristal acetate for uterine fibroids should contact their doctor for advice about other possible treatments for uterine fibroids.

  • Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier?s approved process.
  • Stop prescribing Esmya or generic ulipristal acetate for the treatment of uterine fibroids. No new patients should start treatment with the medicines, which has been suspended throughout the EU during the review. Consider other treatment options as appropriate.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.



Additional information:

NHS England Regional Offices: Please cascade this alert to Community Pharmacy and GP Practices not yet registered with CAS.

You can view further details of this alert by clicking on the following link: View Alert

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The Central Alerting System has been approved by the Review of Central Returns – ROCR. ROCR/OR/0110/006MAND

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