BNF:

6.4

Status:

Do Not Prescribe (DNP)

Decision Date:

March 2020

Comments

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

Do Not Prescribe (DNP) Drug Classifications

• 3: Have known increase in risk of adverse events compared with standard therapy

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