Last reviewed: September 2018
Last updated: September  2018

European Medicines Agency (EMA) restricts the use of ulipristal over liver safety concerns

New restrictions have been placed on the use of ulipristal (Esmya® brand only) for the treatment of women with symptoms of uterine fibroids following a safety review by the EMA. The review was prompted by reports of serious liver problems in women taking the medication, which included four cases of hepatic injury that required liver transplantation. The EMA said uncertainties remained over whether the link was causal but imposed the following new restrictions to minimise risk:

  • Ulipristal is contraindicated in women with known liver problems.

  • It can only be used for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery or for one pre-operative treatment course for moderate to severe symptoms in women of reproductive age.

  • Liver function tests are required before each treatment course, monthly during the first two treatment courses, and then as clinically indicated. Testing should then be repeated 2-4 weeks after stopping treatment. Treatment should not be started if ALT or AST levels are more than 2 times the upper limit of normal (ULN), and it should be stopped if they are more than 3 times ULN.

See Management: approach

Original source of update

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

1st investigations to order

  • ultrasound
  • endometrial biopsy
Full details

Investigations to consider

  • sonohysterography
  • hysteroscopy
  • MRI
  • laparoscopy
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

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 reviewers VIEW 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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