Last reviewed: 6 Feb 2021
Last updated: 09 Dec 2020
09 Dec 2020

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.[82]

Previously, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended revoking the drug’s marketing authorisation for this indication in Europe.[83] 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 pre-menopausal 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 minimise the risk.[84] However, as these cases were followed by another case of severe liver damage resulting in liver transplantation, despite adherence to measures to minimise 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.[86]

Ulipristal is approved as a single-dose medication for emergency contraception in some countries; these restrictions do not apply to this indication.

See Management: emerging

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Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • asymptomatic
  • menorrhagia
  • irregular firm central pelvic mass

Other diagnostic factors

  • pelvic pain
  • pelvic pressure
  • dysmenorrhoea
  • 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

Treatment algorithm

Contributors

Mohamed Mitwally

Medical Director

Reproductive Endocrinology & Infertility

Baptist Medical Center

San Antonio Reproductive Associates

San Antonio

TX

Disclosures

MM declares that he has no competing interests.

Intisar Elnahhas

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 reviewersVIEW ALL

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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