Last reviewed:October 2019
Last updated:October  2019
30 Oct 2019

EMA’s safety committee recommends a 4-week limit for use of high-strength estradiol creams

The European Medicines Agency (EMA)’s pharmacovigilance risk assessment committee (PRAC) has recommended limiting the use of high-strength estradiol vaginal creams (containing 100 micrograms/g or 0.01%) to a single treatment period of up to 4 weeks.[29]

The PRAC review concluded that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels and could result in similar side effects to those seen with systemic (oral or transdermal) hormone therapy (HT). 

The side effects of HT include venous thromboembolism, stroke, endometrial cancer, and breast cancer. 

In the absence of safety data for long-term use of high-strength estradiol creams, the PRAC recommended that these creams should only be used for a single treatment period of a maximum of 4 weeks. This formulation should not be used in patients already on HT. Other vaginal oestrogen formulations are available and may be preferred.

See Management: approachSee Management: treatment algorithm

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • amenorrhoea
  • irregular menstrual cycle
  • hot flushes and night sweats
  • vaginal symptoms
  • mood changes

Other diagnostic factors

  • sleep disturbance
  • mild memory impairment
  • menorrhagia

Risk factors

  • age 40 to 60 years
  • cancer treatment
  • smoking
  • ovarian surgery
  • mother's age at the menopause

Diagnostic investigations

Investigations to consider

  • follicle-stimulating hormone (FSH)
  • serum estradiol
Full details

Treatment algorithm

Contributors

Clinical Director Women and Sexual Health

NHS Dumfries and Galloway

Dumfries and Galloway Royal Infirmary

Scotland

UK

Disclosures

HC declares that she has received sponsorship, educational grants, speaker fees, funding for attendance at meetings, and advisory board fees from several pharmaceutical and non-pharmaceutical companies, which supports the running and development of Menopause Matters Ltd.

Consultant Gynaecologist

Clinical Lead for Menopause Service

King's College Hospital NHS Trust

London

UK

Disclosures

HH declares that he has acted in an advisory capacity for Bayer. HH received a research grant to support a clinical trial and support to attend academic conferences from Besins.

Independence Park Medical Services

Anchorage

AK

Disclosures

BWF is a consultant for Advance Medical and Kevin Trangle Associates and is on the Speakers Bureau for Abbvie.

Dr Heather Currie, Dr Haitham Hamoda, and Dr Bradford W. Fenton would like to gratefully acknowledge Dr Rebekah Wang-Cheng, a previous contributor to this topic.

Peer reviewersVIEW ALL

Assistant Professor

Department of Obstetrics and Gynecology

Virginia Commonwealth University

Richmond

VA

Disclosures

NGOC declares that she has no competing interests.

Internist

Daniel Island

SC

Disclosures

CS declares that she has no competing interests.

Consultant

Honorary Senior Lecturer and Clinical Director

Department of Obstetrics and Gynaecology

Norfolk and Norwich University Hospital

Norwich

UK

Disclosures

EM declares that he has no competing interests.

Professor of Medicine and Obstetrics & Gynecology

Obstetrics and Gynecology

Columbia University in New York Medical Center

New York

NY

Disclosures

MW has received research funding from Ferring and Pfizer Wyeth; has acted as an advisory board consultant for Pfizer Wyeth, QuatRx, and Yoplait; and is on the speakers' bureau of Amgen, Upsher Smith, and Warner Chilcott. MW is also an author of a reference cited in this topic.

Use of this content is subject to our disclaimer