Den europeiske legemiddelmyndighet (EMA) har publisert et nytt tilfelle av leversvikt som førte til levertransplantasjon hos en pasient som sto på Esmya tabletter 5 mg x 1. Derfor anbefales det nå å seponere all Esmya behandling og ikke starte ny behandling mens EMA´s sikkerhetskomite (PRAC) gjør ny gjennomgang av sikkerheten ved ulipristal acetat.
Her er EMA´s anbefalinger:
Information for healthcare professionals
- 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) will be 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.
Information for patients
- 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).
Her er link til EMA´s hjemmeside:
https://www.ema.europa.eu/en/medicines/human/referrals/ulipristal-acetate-5mg-medicinal-products