Advice for healthcare
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
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
- 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,
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.
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
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
Article citation: Drug Safety Update volume 13, issue 8: March 2020: 1.