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
Summary
Definition
History and exam
Key diagnostic factors
- amenorrhea
- irregular menstrual cycle
- hot flashes and night sweats
- vaginal symptoms
- mood changes
Other diagnostic factors
- sleep disturbance
- mild memory impairment
- heavy menstrual bleeding
Risk factors
- age 40 to 60 years
- cancer treatment
- smoking
- ovarian surgery
- mother's age at menopause
Diagnostic tests
1st tests to order
- pregnancy test
Tests to consider
- follicle-stimulating hormone (FSH)
- serum estradiol
Treatment algorithm
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
Contributors
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
Divulgaciones
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
Divulgaciones
HH declares that he has no competing interests.
Bradford W. Fenton, MD, PhD, FACOG
Independence Park Medical Services
Anchorage
AK
Divulgaciones
BWF declares that he has no competing interests.
Agradecimientos
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.
Divulgaciones
RWC declares that she has no competing interests.
Revisores por pares
Nan Gillespie O’Connell, MD
Assistant Professor
Department of Obstetrics and Gynecology
Virginia Commonwealth University
Richmond
VA
Divulgaciones
NGOC declares that she has no competing interests.
Carolyn Simpkins, MD, PhD
Internist
Daniel Island
SC
Divulgaciones
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
Divulgaciones
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
Divulgaciones
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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Referencias
Artículos principales
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. Resumen
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 Resumen
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. Resumen
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. Resumen
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. Resumen
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. Resumen
Artículos de referencia
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Diferenciales
- Pregnancy
- Polycystic ovary syndrome
- Hyperthyroidism
Más DiferencialesGuías de práctica clínica
- Menopause: identification and management
- Recommendations on hormone replacement therapy in menopausal women
Más Guías de práctica clínicaFolletos para el paciente
Menopause: what is it?
Menopausal symptoms: what are the treatment options?
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