Last reviewed: March 2020
Last updated: September  2018
07 Apr 2020

EMA’s safety committee recommends suspension of ulipristal for uterine fibroids during ongoing review of liver injury risk

The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended women stop taking ulipristal for uterine fibroids while a safety review is ongoing. No new patients should start treatment with ulipristal, which will be temporarily suspended throughout the EU during the review.[65]

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.[64] 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 has started a new safety review.

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

See Management: approach

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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 monograph. 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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