CAS alert: Esmya (ulipristal acetate) for uterine fibroids

CAS alert: Esmya (ulipristal acetate) for uterine fibroids

February 10, 2018

A new letter has been published on the Central Alerting System website relating to Esmya (ulipristal acetate) for uterine fibroids to be actioned within 48 hours.

The letter highlights new temporary safety measures which have been introduced for Esmya following reports of serious liver injury in women using the medicine for uterine fibroids in adult women of reproductive age.

Update: the Medicines and Healthcare products Regulatory agency has advised that no new treatment courses should be prescribed until further notice. If women experience symptoms associated with liver problems (nausea, vomiting, feeling ill, lack of appetite, weakness, upper abdominal pain, yellowing of the skin/eyes) then they must stop treatment and seek medical attention immediately.

The emergency contraceptive ellaOne also contains ulipristal acetate (single dose, 30mg). The letter states that no cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.



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