Ulipristal acetate 5mg medicinal products

• Patients should stop taking ulipristal acetate for uterine fibroids (non-cancerous tumours of the womb) while EMA’s safety committee reviews data on the safety of these medicines. The review has started following a case of serious liver injury resulting in liver transplantation that has occurred in a woman taking ulipristal acetate for uterine fibroids.
• If you are taking ulipristal acetate for uterine fibroids, contact your doctor for advice on other possible treatments.
• Consult your doctor or pharmacist if you have any questions or concerns about your treatment.
• Contact your doctor immediately if you develop symptoms of liver injury such as tiredness, loss of appetite, abdominal pain, yellowing of the skin, darkening of the urine, nausea and vomiting.
• There is no concern about liver injury with the single-dose emergency contraceptive containing ulipristal acetate (ellaOne and other trade names).

• Contact your patients currently being treated with ulipristal acetate for uterine fibroids as soon as possible and stop their treatment. Consider other treatment options as appropriate.
• Advise patients to immediately report signs and symptoms of liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia and jaundice).
• Liver function testing should be performed 2-4 weeks after treatment has stopped as described in the product information for the medicines.
• Do not start any new patients on ulipristal acetate for uterine fibroids.
• A direct healthcare professional communication (DHPC) has been sent on or soon after 23 March 2020 to healthcare professionals prescribing or dispensing the medicines. The DHPC will also be published on a dedicated page on the EMA website.

Ulipristal acetate was authorised for treating moderate to severe symptoms of uterine fibroids, which are non-cancerous tumours of the womb, in women who have not reached the menopause. It was used for up to 3 months before women had surgery to remove the fibroids and was also used long-term but with treatment breaks in other women.

Esmya (ulipristal acetate) was authorised throughout the EU in 2012 and Ulipristal Acetate Gedeon Richter in 2018. Generic ulipristal acetate medicines have been authorised via national procedures in several EU countries under various trade names.

More information on Esmya and Ulipristal Acetate Gedeon Richter is available on the EMA website.

The review of Esmya, Ulipristal Acetate Gedeon Richter and generics has been initiated at the request of the European Commission, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. While the review is ongoing, the PRAC has recommended suspending the medicines as an interim measure to protect public health. The recommendation has been forwarded to the European Commission (EC), which issued a provisional legally binding decision applicable in all EU Members States on 25 March 2020.

Once the PRAC review is concluded, the final recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.