Ulipristal acetate is a progesterone receptor modulator that has previously been approved as a postcoital contraceptive; has subsequently been licensed for the treatment of fibroids
Gedeon Richter Plc. in agreement with the European Medicines Agency (EMA), and the Medicines and Healthcare product Regulatory Agency (MHRA) would like to inform you about new restrictions on the use of ulipristal acetate 5 mg and additional measures to minimise the risk of serious liver injury (1):
Cases of serious liver injury (including those necessitating liver transplantation) have followed the use of ulipristal acetate 5 mg for treating moderate to severe symptoms of uterine fibroids.
Ulipristal acetate 5 mg must now be used only for intermittent treatment of moderate to severe symptoms of uterine fibroids in women who have not reached menopause and when uterine fibroid embolisation or surgery are not suitable or have failed.
The physician must discuss with patients the risks and benefits of available alternative treatments so patients can make an informed decision.
The risks of ulipristal acetate 5 mg should be fully explained to patients, especially the risk of liver injury, which could in rare cases lead to liver transplantation.
" The marketing of ulipristal acetate 5mg was suspended while a second European review of the risk of liver injury took place. The review concluded that in addition to the previous measures, the indication of ulipristal acetate 5 mg should be further restricted. The risk of severe liver injury does not justify its use for pre-operative treatment of uterine fibroids.
Prior to prescribing, the prescriber must carefully explain the benefits and risks of ulipristal acetate 5 mg to patients as well as the benefits and risks of alternative treatments so that the patient can make a fully informed decision about the treatment which is most appropriate for her. In particular patients should be told about the risk of liver injury which has in rare cases required liver transplant. Patients should be told the signs and symptoms of liver injury and that if they experience such symptoms, they should stop treatment and contact their doctor immediately. Patients should also be informed of the need for liver monitoring before, during and after treatment courses. For this reason, patients should carefully read the patient alert card included in the medicine’s package.
These measures will be introduced in the summary of product characteristics (SmPC) of ulipristal acetate 5 mg. The Physician’s guide and the patient alert card will also be updated.. (1)"
NICE had previously suggested (2):
Last edited 02/2021