The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that women stop using 5-mg ulipristal acetate (Esmya, Gedeon Richter, and generics) for uterine fibroids while a new review of liver injury risk is ongoing.
“No new patients should start treatment with the medicines, which will be temporarily suspended throughout the EU [European Union] during the review,” the EMA said in a statement on March 13.
The EMA is conducting its review at the request of the European Commission following a recent case of liver injury that led to liver transplant in a woman taking the medicine.
Ulipristal Acetate for Fibroids: Is There A Risk?
As previously reported by Medscape Medical News, the EMA announced a liver safety review of ulipristal acetate in early December 2017.
In early February 2018, the EMA concluded that there is a risk for rare but serious liver injury with ulipristal acetate for the treatment of uterine fibroids, and measures were implemented to minimize the risk, as reported by Medscape Medical News.
“However, as the new case of serious liver injury occurred in spite of adherence to these measures, EMA is starting a new review,” the agency said.
Cases of serious liver injury have been reported in women using ulipristal acetate for fibroids, including five that led to transplant. More than 900,000 patients have been treated with the drug since its authorization in 2012, according to the statement.
Ulipristal acetate reduces the size of uterine fibroids in women who have not yet started menopause by blocking the effects of progesterone. It is used by some women for as long as 3 months before surgical fibroid removal; other women take the drug in repeated courses, with time off between courses.
For now, the EMA advises healthcare providers to take the following actions:
- Contact 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.
- Perform liver function tests 2–4 weeks after treatment has stopped, as described in the product information for the medicines.
- Do not initiate treatment with ulipristal acetate for uterine fibroids for any new patients.
The EMA plans to send a direct healthcare professional communication (DHPC) to providers dispensing ulipristal acetate on or soon after March 23. The DHPC will also be published on a dedicated page on the EMA website.
The EMA said further information and updated recommendations regarding ulipristal acetate for uterine fibroids will be provided once the review is concluded.
Ulipristal acetate is also approved in Europe (and in the United States) for use as a single dose for emergency contraception. The new EMA review does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names), and there is no concern about liver injury with these medicines, the EMA said.
The US Food and Drug Administration has not approved ulipristal acetate for the treatment of uterine fibroids.
Safer Fibroid Treatment: Uterine Fibroid Embolization
The safest and most effective approach to treat fibroids is Uterine Fibroid Embolization (UFE). This is a non-surgical treatment option that allows you to get rid of uterine fibroids without complications and the risk of surgery.
If you are suffering with fibroids, make an appointment to see one of the nation’s leading fibroid experts, John C. Lipman, MD Founder & Medical Director of the Atlanta Fibroid Center by calling 770-214-4600, or make an appointment online.