FDA Removes Black Box Warning Label from Estrogen by Jeffrey Dach MD

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FDA Removes Black Box Warning Label from Estrogen

by Jeffrey Dach MD

On November 10, 2025, Dr. Marty Makary , FDA Commisioner, removed the “black box” warning label from estrogen products. These labels had been in place since 2003 because of the 2002 WHI study. Warnings included increased risk for breast cancer, cardiovascular disease, stroke, blood clots, and probable dementia. This black label warning removal was prompted by a comprehensive review of decades of science, a reanalysis of the Women’s Health Initiative (WHI) and input from an expert panel July 2025. This black warning label created unnecessary fear, leading to massive reduction in use of estrogen despite their proven benefits which include relief from severe menopausal symptoms (e.g., hot flashes, night sweats, vaginal dryness), up to 50% reduced risk of cardiovascular disease and bone fractures, and 35% lower risk of dementia. The 18-Year follow data from the 2004 WHI study shocked the medical world. 10,000 menopausal women were randomized to estrogen or placebo. Compared to the placebo group, the estrogen-alone treated group enjoyed a 45% REDUCTION in mortality from breast cancer. However, when the synthetic hormone MPA was added, these women had a 55% increase in mortality from breast cancer. The lesson learned is: Estrogen is breast cancer protective. However, synthetic progestins (MPA) are carcinogenic!

See the below data chart on 18 year follow up of the Women’s Health Initiative showing 44% reduced mortality from breast cancer in estrogen treated group, and a 55% increased mortality from breast cancer when medroxyprogesterone is added to the estrogen (Premarin).

Above WHI Data Chart Fig 2: Breast Cancer Mortality for First and Second Arms of WHI 18 year follow up. Green Ellipse HR=.55 (45% reduction in breast cancer mortality for Estrogen Alone). Red Ellipse HR= 1.44 (44% increase in breast cancer in E2+MPA) Courtesy of  Manson, JoAnn E., et al. “Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials.” JAMA 318.10 (2017): 927-938. (4)

Alicia Jackson PhD

Here is Alicia Jackson PhD discussing removal of the FDA warning label on estrogen:

Alicia Jackson PhD (MIT) is Director of the Advanced Research Projects Agency for Health (ARPA-H), an HHS agency since October 2025.
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Dr. Jen Gunter

Dr. Jen Gunter is a Canadian board-certified OB/GYN physician specializing in women’s reproductive health writes:

I want to be clear, I do not believe the medical literature supports the current black box warning for vaginal estrogen. The purpose of a black box warning is to call attention to serious or life-threatening risks, and as I’ll discuss below, many of the risks on the label do not reflect the literature. (1)

Dr. Jen Gunter is currently at Kaiser Permanente in San Francisco, California. Dubbed “Twitter’s Resident Gynecologist,” Dr. Gunter is a Canadian-American author, podcaster, and advocate known for her no-nonsense, science-driven approach to women’s health. She has authored several New York Times bestsellers, including The Vagina Bible (2019), The Menopause Manifesto (2021), and Blood: The Science of Menstruation (2024), which address common misconceptions and offer practical advice. Gunter has contributed to outlets like The New York Times and hosted the podcast Body Stuff with Dr. Jen Gunter. (1)

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Lawrence M. Nelson, MD writes:

The FDA’s step [removing the warning label] is more than regulatory housekeeping – it is a moral acknowledgment that fear-based labeling misled a generation. The much-needed subsequent correction must be ours: to retire outdated, culturally loaded, bikini-style medical terminology and replace it with accurate, biological endocrine language….When we speak truthfully, we restore integrity in science, in language, and in policy. Reference: Nelson, L. M. (2023). The Truth About 17-Beta Estradiol: Menopause Beyond “Old Wives’ Tales.” Frontiers in Endocrinology. (2-3)

Dr. Lawrence M. Nelson, MD, is a retired gynecologist and reproductive endocrinologist specializing in women’s health. Since retirement in 1917, Dr. Lawrence has been director of My 28 Days initiative (my28days.org).

Note: The warning label concerning estrogen’s increased risk for endometrial cancer has NOT been removed. However, this increased risk of endometrial cancer is eliminated with the concurrent use of progesterone.

If you liked this article, you might like my new book, Bioidentical Hormones 101, 2nd Edition (2025), paperback and ebook on Amazon. 

Click Here for link to Paperback Version of Bioidentical Hormones 101 second edition (2025). The paperback contains all three volume ebooks.

Free Video Introduction to Book:

Introduction Video to Bioidentical Hormones 101 Second Edition (2025)

Bioidentical Hormones for Breast Cancer Survivors  Video Presentation

Link to my Free e-Book Bioidentical Hormones 101

Articles with Related Interest:

Errors in Modern Medicine, the Fear of Estrogen

Hormone Replacement for Breast Cancer Survivors Part One

Hormone Replacement for Breast Cancer Survivors Part Two

Estrogen Metabolism, Iodine, 2MEO Part Three

Testosterone for Breast Cancer Prevention and Treatment

Introduction Video to Bioidentical Hormones 101 Second Edition (2025)

All Bioidentical Hormone Articles by Jeffrey Dach MD

The Safety of Transdermal Estrogen Part One

The Safety of Transdermal Estrogen vs. Oral Estrogen Part Two

Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Fl 33314
954-792-4663

References:

1) The Black Box Warning on Vaginal Estrogen Might Be Wrong — and the Science Still Isn’t Complete. The FDA’s open docket is a rare chance to fix both, and here’s how you can contribute The Vajenda By Dr. Jen Gunter Aug 10, 2025

2) FDA Removes Black Box Warnings on Estrogen Products
November 12, 2025 Doctor Lawrence

3) Nelson, Lawrence M. “The truth about 17-beta estradiol: menopause beyond “old wives’ tales”.” Frontiers in Endocrinology 14 (2023): 1229804.

4) Manson, JoAnn E., et al. “Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials.” JAMA 318.10 (2017): 927-938. (1)

Header Image: FDA Black Box Warning for Estrace.

Jeffrey Dach MD
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954-792-4663
my blog: www.jeffreydachmd.com 
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