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
Resumo
Definição
História e exame físico
Principais fatores diagnósticos
- amenorrhea
- irregular menstrual cycle
- hot flashes and night sweats
- vaginal symptoms
- mood changes
Outros fatores diagnósticos
- sleep disturbance
- mild memory impairment
- heavy menstrual bleeding
Fatores de risco
- age 40 to 60 years
- cancer treatment
- smoking
- ovarian surgery
- mother's age at menopause
Investigações diagnósticas
Primeiras investigações a serem solicitadas
- pregnancy test
Investigações a serem consideradas
- follicle-stimulating hormone (FSH)
- serum estradiol
Algoritmo de tratamento
initial presentation with mild vasomotor symptoms
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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Declarações
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Referências
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 diferenciaisDiretrizes
- Menopause: identification and management
- Recommendations on hormone replacement therapy in menopausal women
Mais DiretrizesFolhetos informativos para os pacientes
Menopause: what is it?
Menopausal symptoms: what are the treatment options?
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