Ulipristal Acetate (Esmya)

MHRA (February 2021) Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury.

MHRA (March 2020) suspended the licence of Esmya (ulipristal acetate) due to risk of serious liver injury.

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 hypochondriac 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