Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury
Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. The licence for Esmya has been suspended to protect public health while a safety review is conducted following a further case of liver injury requiring transplant.
Post-publication note: February 2021
This article has been superseded. The temporary suspension for Esmya has now been lifted and the indications restricted. For information on the restricted indications and reminders of the liver monitoring requirements, see Drug Safety Update February 2021.
Post-publication note: November 2020
On 12 November 2020, the Committee on Medicinal Products for Human Use (CHMP) recommended that the licences for Esmya (and generics) should remain on the market with a restricted indication. The CHMP recommended that these medicines now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment. This recommendation will now be forwarded to the European Commission for a decision. Further information will follow.
Advice for healthcare professionals:
-
contact patients currently being treated with Esmya as soon as possible and stop their treatment; discuss alternative treatment options for uterine fibroids as appropriate
-
do not start any new patients on Esmya
-
advise recent users to seek immediate medical attention if they develop signs and symptoms of liver injury (nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice)
-
perform liver function tests 2–4 weeks after stopping Esmya as recommended in the product information
-
report suspected adverse drug reactions without delay to the Yellow Card scheme
-
there are no concerns with emergency contraceptive ellaOne (ulipristal acetate 30mg single dose) at this time
Advice to give to patients
- stop taking Esmya and contact your doctor for advice about other possible treatments for uterine fibroids
- attend appointments for liver function testing after stopping Esmya treatment as advised by your doctor
- seek medical advice immediately if you develop symptoms of liver injury such as abdominal pain, yellowing of the skin or eyes, dark urine, tiredness, loss of appetite, and nausea and vomiting, even if 1–2 months after stopping Esmya treatment
- there are no concerns with emergency contraceptive ellaOne (ulipristal acetate 30mg, single-dose) at this time
Review of serious liver injury
Ulipristal acetate 5mg (Esmya) is authorised for moderate to severe symptoms of uterine fibroids in women who had not reached the menopause.
On 9 March 2020, the European Medicines Agency (EMA) started a review of Esmya following a new case of liver failure requiring liver transplant. This case occurred despite the patient and physician having adhered to measures that were put in place following a previous review to minimise the risk of liver injury, namely measuring liver function before and during treatment, and stopping treatment immediately in case of raised liver enzyme levels.
This is now the fifth case of liver injury requiring liver transplant reported worldwide in women receiving Esmya.
To protect public health, marketing authorisations for all ulipristal acetate 5mg products for uterine fibroids will be suspended in the UK for the duration of the review. Patients currently taking Esmya for uterine fibroids should stop taking the medicine and no new patients should start treatment. We will communicate the recommendations of the review once finalised.
The MHRA has issued a recall of Esmya from pharmacies, wholesalers, and patients, and the manufacturer will send a letter to UK prescribers and dispensers on 23 March 2020.
Since authorisation and to date, we have received 19 suspected adverse drug reaction reports of liver disorders with the use of Esmya in the UK. None report liver transplant or death. Approximately 2,865 treatment courses of Esmya were dispensed in the UK in 2019.[footnote 1]
The emergency contraceptive ellaOne also contains ulipristal acetate (single dose, 30mg). There are no concerns with this medicine at this time.
Report suspected adverse drug reactions
Report without delay any suspected adverse drug reactions (ADRs) 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.
Healthcare professionals, patients, and caregivers can report suspected ADRs via the Yellow Card website or via the Yellow Card app. Download the app today via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices. You can also view recent alerts from the MHRA and read Drug Safety Updates through the App newsfeed.
Article citation: Drug Safety Update volume 13, issue 8: March 2020: 1.
-
Data derived from IQVIA MIDAS 01/2019 – 12/2019, by the MHRA, March 2020. The assumption was made that each course was 3 months duration, however a patient could take this drug for less than 3 months. It also needs to be taken into consideration, that there is variability in the number of courses a patient will take (between 1 and 4). The number of courses quoted is a broad estimation and therefore is not equivalent to the number of patients who used this product. ↩