Last reviewed: 16 Aug 2021
Last updated: 09 Sep 2021
04 Jun 2021

The UK MHRA recommends further restricting the use of ulipristal for uterine fibroids

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recommended that the use of ulipristal be further restricted as a result of cases of serious liver injury.[145]

Ullipristal was first authorized in 2012 for intermittent or preoperative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age. In 2018, the European Medicines Agency (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.[146] 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 MHRA also issued a drug safety update for ulipristal that provided similar advice.[148]

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended revoking the drug’s marketing authorization for this indication in Europe.[149] But, after careful consideration, they 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).[144] Ulipristal must not be used for controlling uterine fibroids in women who are awaiting surgical treatment.

The MHRA have now also agreed that the temporary suspension should be lifted but that the use of ulipristal should be further restricted to intermittent therapy of women with moderate to severe uterine fibroid symptoms before the menopause when surgical procedures (including uterine fibroid embolization) are unsuitable or have failed.[145]

See Management: emerging

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Summary

Definition

History and exam

Key diagnostic factors

  • asymptomatic
  • heavy menstrual bleeding
  • irregular firm central pelvic mass

Other diagnostic factors

  • pelvic pain
  • pelvic pressure
  • dysmenorrhea
  • bloating
  • fatigue and loss of productivity in working
  • infertility
  • urinary complaints
  • constipation
  • enlarged uterus (regular contour)
  • dyspareunia

Risk factors

  • increased patient weight
  • age in the 40s
  • black ethnicity
  • hypovitaminosis of vitamin D
  • hypertension
  • early menarche (under 10 years)
  • use of oral contraceptives (if started before age 16 years)
  • nulliparity
  • younger age at first birth
  • poor vitamin A intake
  • dietary intake high in beef and other red meat
  • sex hormone exposure
  • menstrual history
  • smoking
  • alcohol consumption

Diagnostic investigations

Investigations to consider

  • sonohysterography
  • hysteroscopy
  • MRI
  • laparoscopy

Emerging tests

  • sonoelastography
  • MR elastography

Treatment algorithm

Contributors

Authors

Ayman Al-Hendy, MD PhD FRCSC FACOG CCRP

Professor (visiting) and Director

Translational Research

Department of Obstetrics and Gynecology

University of Illinois

Chicago

IL

Disclosures

AAH serves on the external advisory board of Bayer, AbbVie, Myovant, and Allergan, and has received research funding from the National Institutes of Health. AAH is an author of references cited in this topic.

Obianuju Sandra Madueke-Laveaux, MD MPH

Assistant Professor of Obstetrics and Gynecology

Department of Obstetrics and Gynecology

University of Illinois

Chicago

IL

Disclosures

OSML declares that she has no competing interests. OSML is an author of references cited in this topic.

Vuslat Lale Bakir, MD

Assistant Professor of Obstetrics and Gynecology

Department of Obstetrics and Gynecology

Haseki Training and Research Hospital

Health Sciences University

Istanbul

Turkey

Disclosures

VLB declares that she has no competing interests.

Acknowledgements

Dr Al-Hendy, Dr Madueke-Laveaux, and Dr Bakir would like to gratefully acknowledge Dr Mohamed Mitwally, Dr Intisar Elnahhas, and Dr Robert J. Fischer, the previous contributors to this topic.

Disclosures

MM, IE, and RJF declare that they have no competing interests.

Peer reviewers

Everett Magann, MD

Chairman

Department of Obstetrics and Gynecology

Naval Medical Center

Portsmouth

VA

Disclosures

EM declares that he has no competing interests.

Amy Niederhauser, MD

Doctor

Department of Obstetrics and Gynecology

Naval Medical Center

Portsmouth

VA

Disclosures

AN declares that she has no competing interests.

Adam Magos, BSc, MB, BS, MD, FRCOG

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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