The European Medicines Agency has issued temporary recommendations relating to use of Esmya® (ulipristal acetate) for management of uterine fibroids, pending completion of a safety review. The EMA states that there are no concerns at this time regarding the safety of ellaOne® used for emergency contraception. FSRH recommendations for use of ellaOne remain unchanged.
Ulipristal acetate for emergency contraception: FSRH CEU guidance in response to European Medicines Agency recommendations regarding use of ulipristal acetate for management of uterine fibroids.
The European Medicines Agency (EMA) is currently reviewing the safety of use of Esmya® (ulipristal acetate) for management of uterine fibroids. This review follows reports of a very small number of cases worldwide of serious liver injury in women using Esmya. Until the review process is complete, temporary restrictions have been placed on commencing treatment with Esmya and guidelines for monitoring liver function in women already taking Esmya have been introduced. The EMA recommendations are available online here.
Ulipristal acetate is also the active ingredient of the oral emergency contraceptive, ellaOne®. In comparison to Esmya, which is taken daily for several months, ellaOne is taken as a single dose on an occasional basis for emergency contraception. The EMA is clear that no cases of serious liver injury have been reported with ellaOne and there are no concerns regarding ellaOne at this time.
In line with this recommendation, the FSRH CEU reassures FSRH members that FSRH recommendations regarding use of ellaOne for contraception remain unchanged at this time. The FSRH Emergency Contraception guideline can be found online here.
Download this statement in full below.
By: FSRH CEU 11/2/18