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Menopause

Última revisão das evidências: 23 Apr 2026
Última atualização do tópico: 21 Apr 2026
18 Mar 2026

Food and Drug Administration (FDA) approves labeling changes to menopausal hormone therapies

The FDA has approved the removal of black box warnings for six hormone therapies, to clarify the risks of cardiovascular disease, breast cancer, and probable dementia, following a comprehensive review of the scientific literature.

Randomized studies show women who initiate hormone therapy within 10 years of the beginning of menopause, particularly before age 60 years have a reduction in all-cause mortality and fractures.

The FDA is recommending these labeling changes so that women and healthcare professionals have access to updated information on the benefits and risks of these therapies and can make better informed decisions about using them.

The updated labeling includes drugs in all four categories of hormone therapy:

  • Systemic combination therapy (estrogen and progestogen)

  • Systemic estrogen-only therapy

  • Systemic progestogen-only therapy (for women with a uterus using systemic estrogen)

  • Topical vaginal estrogen therapy

Ver Tratamento: abordagem

Fonte original da atualização

Resumo

Definição

História e exame físico

Principais fatores diagnósticos

  • amenorrhea
  • irregular menstrual cycle
  • hot flashes and night sweats
  • vaginal symptoms
  • mood changes
Detalhes completos

Outros fatores diagnósticos

  • sleep disturbance
  • mild memory impairment
  • heavy menstrual bleeding
Detalhes completos

Fatores de risco

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

Investigações diagnósticas

Primeiras investigações a serem solicitadas

  • pregnancy test
Detalhes completos

Investigações a serem consideradas

  • follicle-stimulating hormone (FSH)
  • serum estradiol
Detalhes completos

Algoritmo de tratamento

AGUDA

initial presentation with mild vasomotor symptoms

CONTÍNUA

women with a uterus, moderate to severe hot flashes, with/without reduced libido

women without a uterus or with levonorgestrel-releasing intrauterine device fitted in the last 5 years, moderate to severe hot flashes, with/without reduced libido

urogenital atrophy only

urinary stress incontinence only

Colaboradores

Autores

Heather Currie, MB BS, FRCOG, DRCOG, MRCGP

Clinical Director Women and Sexual Health

NHS Dumfries and Galloway

Dumfries and Galloway Royal Infirmary

Scotland

UK

Declarações

HC declares that she has no competing interests.

Haitham Hamoda, MBChB, MD, FRCO

Consultant Gynaecologist

Clinical Lead for Menopause Service

King's College Hospital NHS Trust

London

UK

Declarações

HH declares that he has no competing interests.

Bradford W. Fenton, MD, PhD, FACOG

Independence Park Medical Services

Anchorage

AK

Declarações

BWF declares that he has no competing interests.

Agradecimentos

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.

Declarações

RWC declares that she has no competing interests.

Revisores

Nan Gillespie O’Connell, MD

Assistant Professor

Department of Obstetrics and Gynecology

Virginia Commonwealth University

Richmond

VA

Declarações

NGOC declares that she has no competing interests.

Carolyn Simpkins, MD, PhD

Internist

Daniel Island

SC

Declarações

CS declares that she has no competing interests.

Edward Morris, MD

Consultant

Honorary Senior Lecturer and Clinical Director

Department of Obstetrics and Gynaecology

Norfolk and Norwich University Hospital

Norwich

UK

Declarações

EM declares that he has no competing interests.

Michelle Warren, MD

Professor of Medicine and Obstetrics & Gynecology

Obstetrics and Gynecology

Columbia University in New York Medical Center

New York

NY

Declarações

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.

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Referências

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Principais artigos

Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol. 2005 May;105(5 Pt 1):1063-73. Resumo

Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9.Texto completo  Resumo

North American Menopause Society. Management of osteoporosis in postmenopausal women: the 2021 position statement of The North American Menopause Society. Menopause. 2021 Sep 1;28(9):973-97. Resumo

The North American Menopause Society Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022 Jul 1;29(7):767-94. Resumo

Bofill Rodriguez M, Yong LN, Mirkov S, et al. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2025 Nov 27;11(11):CD004143. Resumo

Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the women's health initiative randomized trials. JAMA. 2017 Sep 12;318(10):927-38. Resumo

Artigos de referência

Uma lista completa das fontes referenciadas neste tópico está disponível para os usuários com acesso total ao BMJ Best Practice.
  • Diagnósticos diferenciais

    • Pregnancy
    • Polycystic ovary syndrome
    • Hyperthyroidism
    Mais Diagnósticos diferenciais
  • Diretrizes

    • Menopause: identification and management
    • Recommendations on hormone replacement therapy in menopausal women
    Mais Diretrizes
  • Folhetos informativos para os pacientes

    Menopause: what is it?

    Menopausal symptoms: what are the treatment options?

    Mais Folhetos informativos para os pacientes
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