PRAC recommends suspending the use of ulipristal acetate for the treatment of uterine fibroids during the ongoing review of the risk of liver injury
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicinal products) for the treatment of uterine fibroids while the safety review is ongoing. No new patient should start treatment with products that will be temporarily banned throughout the EU during the review.
The EMA is starting its review at the request of the European Commission following a recent case of liver injury that led to a liver transplant in a patient who was taking the medicine.
The EMA review of 2018 concluded that there is a risk of rare but serious liver injury with medicines containing ulipristal acetate for the treatment of uterine fibroids, and risk minimization measures were taken. However, since a new case of serious liver injury occurred despite compliance with these measures, the EMA is starting a new review.
Cases of serious liver injury have been reported, including 5 cases that led to transplantation, among more than 900 000 patients who have received ulipristal acetate for uterine fibroids since its authorization in 2012.
Ulipristal acetate is also authorized as a single-dose medicine for emergency contraception. This review does not concern the use of ulipristal acetate for emergency contraception (ellaOne and other trade names), and there are no concerns about liver injury with these medicinal products.
More detailed information and updated recommendations will be provided after the review is completed
Information for patients
- Patients should stop taking ulipristal acetate for uterine fibroids (non-cancerous tumors of the uterus) while the EMA safety committee reviews the safety data for this medicine. The review began after cases of serious liver injury leading to a liver transplant in a woman who had taken ulipristal acetate to treat uterine fibroids.
- If you are taking ulipristal acetate for uterine fibroids, consult your doctor about other possible treatment options.
- Consult your doctor or pharmacist if you have any questions or concerns about your treatment.
- Seek medical attention immediately if you develop symptoms of liver injury, such as fatigue, loss of appetite, abdominal pain, yellowing of the skin, dark urine, nausea and vomiting.
- Liver injury is not a concern with the single-dose emergency contraceptive containing ulipristal acetate (ellaOne and other trade names).
Information for healthcare professionals
Contact patients who are currently being treated with ulipristal acetate for uterine fibroids and discontinue their treatment. Consider other treatment options where appropriate.
Advise patients to report immediately any signs and symptoms of liver injury (such as nausea, vomiting, right upper quadrant pain, anorexia, asthenia and jaundice).
Liver function testing should be performed 2-4 weeks after discontinuation of treatment, as described in the product information.
Treatment with ulipristal acetate for uterine fibroids should not be started in new patients.
The notification of the direct healthcare professional communication (DHPC) will be sent on October 23, 2020, or shortly thereafter, to healthcare professionals who prescribe or dispense medicines. The DHPC will also be published on a dedicated page of the EMA website.
More about medicines
Ulipristal acetate was authorized for the treatment of moderate to severe symptoms of uterine fibroids, which are noncancerous tumors of the uterus, in women who have not reached menopause. It was used for up to 3 months before women underwent surgery to remove fibroids, and was also used long term, but with treatment breaks, in other women.
Esmya (ulipristal acetate) was authorized throughout the EU in 2012, and Ulipristal Acetate Gedeon Richter in 2018. Generic ulipristal acetate products were authorized under national procedures in several EU countries under various trade names.
More information about Esmya and Ulipristal Acetate Gedeon Richter is available on the EMA website.
More about the procedure
The review of Esmya, Ulipristal Acetate Gedeon Richter and generics was initiated at the request of the European Commission pursuant to Article 31 of Directive 2001/83 / EC.
The review is conducted by the Committee for Risk Assessment in Pharmacological Hygiene (PRAC), the committee responsible for assessing safety issues of medicinal products for human use, which will issue a number of recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use ( CHMP ), which is responsible for questions concerning medicinal products for human use and 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.
Link to the EMA press release:
https://www.ema.europa.eu/en/medicines/human/referrals/ulipristal-acetate-5mg-medicinal-products
https://www.ema.europa.eu/en/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-review-started_en.pdf
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