Ulipristal acetate

Grey

Brand Name(s):Esmya

Indication:Pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Heavy menstrual bleeding & fibroids

Rationale:

Considered:Jan-12

Review Date:Jul-23

Comments:
MHRA
Esmya (ulipristal acetate) for symptoms of uterine fibroids: restrictions to use and requirement to check liver function before, during and after treatment
Aug 18
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Drug safety update
Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
March 2018
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NICE CG44(update)
Heavy menstrual bleeding: assessment and management
Feb 2018
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NICE CG44(update)
Heavy menstrual bleeding: assessment and management
Aug 2016 Update 2020 – Recommendation from PRAC that the drug be supended. Pharmacovigilance Risk Assessment Committee (PRAC) recommends suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk