Five reports of serious liver injury, including four cases of hepatic failure needing liver transplantation, have been reported worldwide in women using Esmya for uterine fibroids.
The following temporary safety measures have been introduced while an EU-wide review of the evidence is ongoing:
- 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. Stop Esmya treatment in any woman who develops transaminase levels more than 2 times the upper limit of normal, closely monitor and refer for specialist hepatology evaluation as clinically indicated. Liver function tests should be repeated in all women 2 to 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 (such as nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice). If transaminase levels are more than 2 times the upper limit of normal, stop treatment, closely monitor and refer for specialist hepatology evaluation as clinically indicated.
- Advise women using Esmya on the signs and symptoms of liver injury.
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.
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.