EMA recommends restricting the use of ulipristal for uterine fibroids
The European Medicines Agency (EMA) has recommended that the use of ulipristal be restricted as a result of cases of serious liver injury.[83]
Previously, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended revoking the drug’s marketing authorization for this indication in Europe.[84] But, after careful consideration, they have confirmed the benefits of ulipristal in controlling uterine fibroids might outweigh this risk in women who have no other treatment options. Therefore, they now recommend that ulipristal remains available to treat premenopausal women who cannot have surgery (or for whom surgery had not worked). Ulipristal must not be used for controlling uterine fibroids in women who are awaiting surgical treatment.
In 2018, the EMA reviewed the benefits and risks of ulipristal for the treatment of uterine fibroids following reports of serious liver injury, including liver failure leading to transplantation and measures were implemented to minimize the risk.[85] However, as these cases were followed by another case of severe liver damage resulting in liver transplantation, despite adherence to measures to minimize the risk, the EMA started a new safety review in early 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) also issued a drug safety update for ulipristal that provided similar advice.[87]
Ulipristal is approved as a single-dose medication for emergency contraception in some countries; these restrictions do not apply to this indication.
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Summary
Definition
History and exam
Key diagnostic factors
- asymptomatic
- menorrhagia
- irregular firm central pelvic mass
Other diagnostic factors
- pelvic pain
- pelvic pressure
- dysmenorrhea
- bloating
- infertility
- urinary complaints
- constipation
- enlarged uterus (regular contour)
Risk factors
- increased patient weight
- age in the 40s
- black ethnicity
- hypertension
- dietary intake high in beef and other red meat
- sex hormone exposure
- menstrual history
- obstetric history
Diagnostic investigations
Investigations to consider
- sonohysterography
- hysteroscopy
- MRI
- laparoscopy
Treatment algorithm
Contributors
Authors

Medical Director
Reproductive Endocrinology & Infertility
Baptist Medical Center
San Antonio Reproductive Associates
San Antonio
TX
Disclosures
MM declares that he has no competing interests.

Laboratory Director
San Antonio Reproductive Associates
Odessa Reproductive Medicine Center
San Antonio
TX
Disclosures
IE declares that she has no competing interests.
Dr Mitwally and Dr Elnahhas would like to gratefully acknowledge Dr Robert J. Fischer the previous contributor to this topic. RJF declares that he has no competing interests.
Peer reviewers
Chairman
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
Disclosures
EM declares that he has no competing interests.
Doctor
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
Disclosures
AN declares that she has no competing interests.
Consultant Gynaecologist
University Department of Obstetrics and Gynaecology
Royal Free Hospital
London
UK
Disclosures
AM declares that he has no competing interests.
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