Ulipristal Acetate (Esmya)
- 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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