Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.
Post-publication note: February 2021
This advice has now been superseded. A further EU review of liver safety restricted the indicated population for Esmya for safety reasons and introduced additional measures to minimise risk of liver injury. For more information on the restricted indication and liver monitoring requirements, see Drug Safety Update, February 2021.
Post-publication note
This advice has now been superseded. The EU review restricted the indicated population for Esmya for safety reasons and introduced measures to minimise risk of liver injury. In particular, more than one treatment course is now authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. See Drug Safety Update, August 2018 for more information
Advice for healthcare professionals:
- do not initiate new treatment courses of Esmya, including in women who have completed one or more treatment courses previously
- perform liver function tests at least once a month in all women currently taking Esmya and again 2–4 weeks after stopping treatment.
- check transaminase levels immediately in current or recent users of Esmya who present with signs or symptoms suggestive of liver injury (for example nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia, or jaundice)
- stop Esmya in any woman who develops transaminase levels more than 2-times the upper limit of normal, closely monitor and refer women for specialist hepatology evaluation as clinically indicated
- advise women using Esmya about the signs and symptoms of liver injury and tell them to seek immediate medical attention if they occur
- report suspected adverse drug reactions without delay to the Yellow Card Scheme
Review of liver safety
An EU-wide review of Esmya started in December 2017 following reports of serious liver injury in women using the medicine. The review is ongoing; however, temporary safety measures were introduced in February 2018 to protect women’s health pending finalisation of the investigation. These measures were considered necessary following receipt of the fifth case of hepatic failure (the fourth that required liver transplantation). We will provide further information as soon as the EU review is completed. Further information about the review can be found on the website of the European Medicines Agency.
Healthcare professionals were informed of the temporary safety measures by the MHRA through a notice on the Central Alerting System and the Marketing Authorisation Holder has sent a letter to prescribers in the UK. The European Medicines Agency has issued information to both healthcare professionals and women, available on their website.
To date, we have received 1 suspected adverse drug reaction report of hepatitis with the use of Esmya in the UK. Approximately 20,400 treatment courses of Esmya were dispensed in the UK between 1 October 2016 and 30 September 2017.[footnote 1]
The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.
Background
Esmya was first authorised in 2012 for intermittent or pre-operative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age. Each treatment course of 5mg daily lasts for up to 3 months and may be repeated with breaks between each course.
Report suspected adverse drug reactions to Esmya
It is important that you report without delay any suspected adverse drug reactions associated with Esmya, including signs or symptoms of liver injury, to the Yellow Card Scheme. The Yellow Card Scheme is vital in helping the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them.
Article citation: Drug Safety Update volume 11 issue 8; March 2018: 2.
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Data derived from IQVIA MIDAS 10/2016-09/2017 by MHRA, January 2018. The usage estimate is based on the assumption that each treatment course was of 3 months’ duration. The number of courses each woman takes may vary between 1 and 4 courses. The number of courses quoted is a broad estimation and is not therefore equivalent to the number of women who used Esmya ↩