FDA Remove Estrogen therapy Warning in Win for Women’s Health

For more than two decades, millions of women were told to fear the very therapy that could have protected their hearts, bones, and minds. That fear ended this week.

The U.S. Food and Drug Administration has officially removed its black box warning from hormone therapy for women, acknowledging what the scientific evidence has shown for years. This change is not just a policy update, it is a long-overdue correction to decades of medical misunderstanding and fear-based medicine. For women everywhere, it marks the beginning of a new era in hormone health.

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A Historic Day for Women's Health

The black box warning, added in the early 2000s, was based on initial interpretations of the Women's Health Initiative (WHI) trials. Early headlines suggested that hormone therapy increased the risk of breast cancer, heart disease, and stroke. Subsequent analyses have shown that these early messages overstated risks for many women and did not reflect the full data picture, particularly for women who start therapy earlier in the menopausal transition. ^{1 2}

"Before the panic, one in four women used hormone replacement therapy. Today, it's fewer than one in twenty. That's not progress. That's neglect. That's malpractice."
- Robert F. Kennedy Jr. (FDA event remarks)

Since then, millions of women have endured unnecessary suffering. Hot flashes, night sweats, sleep disruption, mood changes, depression, and bone loss became something they were told to "tough out." Many clinicians, shaped by the warning, stopped prescribing hormone therapy altogether or discussed it with fear and hesitation. ^{1 3}

Today, that narrative begins to change.

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The Long Road to This Moment

The WHI results were released to the media before the full data and nuance were widely understood. Later, more detailed evaluations clarified that:

• In appropriately selected women, especially those who start near menopause, absolute risks are low. ^{1 2}
  
• In the estrogen-only arm (women with prior hysterectomy), breast cancer incidence and mortality were not increased, and in some analyses were reduced. ¹
  

Over the last two decades, high-quality evidence and guidelines from major medical societies have converged:

• Menopausal hormone therapy (MHT) is the most effective treatment for vasomotor symptoms. ^{2 5}
  
• Starting MHT before age 60 or within 10 years of menopause is associated with a more favorable risk-benefit profile, including cardiovascular outcomes. ^{2 3 6}
  
• Modern guidance supports individualized prescribing rather than blanket fear. ^{2 6 7}
  

The science has been moving in this direction for years. The FDA decision is the policy catching up.

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The Cost of Fear

Before 2002, nearly one in four postmenopausal women in the United States used hormone therapy as standard care. ¹ After the WHI headlines and the black box warning, use dropped sharply. Long-term analyses and guideline reviews confirm that systemic hormone therapy use fell to well under 10 percent, often closer to 5 percent, despite persistent and severe symptoms in the majority of menopausal women. ^{1 7}

Today, fewer than one in twenty women use hormone therapy, down from one in four before 2002. ^{1 7} This translates into tens of millions of women who have been deterred from evidence-based treatment that could have improved quality of life and, for some, long-term health.

"If a patient does get a prescription from her doctor and brings it home, nearly one in three will never use it because of the fear created by the incorrect warning label."
- Dr. Kelly Casperson (FDA event remarks)

That single label helped create two lost decades for women's health. It shaped medical education, media narratives, and patient trust. It made normal physiology feel dangerous and left many women to suffer in silence.

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What the Science Now Confirms

Estrogen affects the brain, blood vessels, bones, metabolism, skin, mood, and sexual health. ⁵

Current evidence and major position statements show that, for appropriately selected women:

• MHT is the most effective treatment for vasomotor symptoms and genitourinary syndrome of menopause. ^{2 5 7}
  
• MHT helps prevent bone loss and reduces fracture risk.^{2 5 7}
  
• When initiated in younger, recently menopausal women, MHT is associated with more favorable cardiovascular profiles and has not been shown to increase all-cause mortality in WHI follow-up. ^{3 4 6}
  
  

In other words, when used correctly, hormone therapy is a powerful, evidence-based tool for symptom relief and long-term health support, not the universal threat it was made out to be.

Policy makers are now at last supporting the protocol we built nearly 20 years ago. When started at the right time and properly tailored, hormone therapy can be life-changing, helping women protect their hearts, preserve vitality, and age with strength and confidence. ^{3 6 7}

"More than 40 studies show a consistent 30 to 50 percent reduction in heart disease in HRT users compared to non-users."
- Dr. Marty Makary (FDA event remarks)

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Fem Excel's Perspective

At Fem Excel, we have always believed women deserve proactive, data-driven care, not fear-based avoidance.

Our medical team, led by Dr. Lorna Brudie and Dr. Peter Fotinos, has long prescribed hormone therapy in alignment with emerging evidence and international guidance:

• Personalized care: Every woman's regimen is based on her history, symptoms, goals, and labs.
  
• Evidence-based protocols: We align with major guidelines and peer-reviewed data on timing, formulation, and safety. ^{2 5 6 7}
  
• Proactive health: We view hormones as part of integrated prevention for bone, brain, metabolic, and cardiovascular health, as well as part of a cancer prevention strategy.

Ultimately, the FDA's move does not change how we practice at Fem Excel. It now validates it and gives women the peace of mind that was stolen all these years ago.

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The Excel Advantage

Most primary care physicians and OB/GYNs receive very few hours of formal education in menopause and hormone therapy throughout their entire training. That lack of understanding is one of the main reasons women have been left behind for two decades. The FDA's decision should now signal something bigger. It should mark a national call for proper training, evidence-based guidance, and true expertise in women's hormone health.

Fem Excel is already there. Our providers are not part-time contractors or generic telehealth prescribers. They are trained in The Excel Advantage, our proprietary hormone optimization framework built from over 30 years of clinical experience.

• Most clinicians receive fewer than 10 hours of menopause training across medical school and residency.
• Fem Excel providers complete over 100 hours of dedicated training each year in hormone optimization, thyroid health, and metabolic care.
• We do not use external "rent-a-doctor" networks. Every provider is employed, supervised, and continuously educated in-house to ensure consistency and safety.
• We continuously advance our protocols through ongoing research and training to ensure our treatments remain at the forefront of hormone optimization.

Fem Excel began as a brick-and-mortar practice and expanded online so more women could access real, evidence-based care. We did not follow a trend... we built the standard. We wrote the playbook that others are only now trying to imitate, and the FDA has finally caught up.

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Why This Decision Matters for Women

The removal of the black box warning does more than change the packaging insert. It resets the conversation.

It tells women and clinicians:

• Menopause symptoms are real and deserve treatment.
  
• Hormone therapy, when individualized and started at the right time, is a legitimate, evidence-supported option. ^{2 5 6 7}
  
• Risk should be discussed in context, not used to scare women away from care.
  

Menopause is not a single moment, it is a transition that can span years and affect sleep, mood, relationships, work, and long-term health. ^{5 7} When hormones are restored appropriately, women often regain clarity, stability, strength, and quality of life. Not to mention improvement in overall longevity and mortality.

“Women deserve the same rigorous science that is used for men. We do not believe in medical dogma. We believe in evidence, science, and restoring the doctor-patient relationship.”
- Dr. Marty Makary

Cardiovascular disease remains the leading cause of death in women. Updated guidance emphasizes that for many symptomatic women under 60 or within 10 years of menopause onset, the benefits of hormone therapy can be significant. ^{2 3 6 7} That is a profound shift from the fear narrative of 2003.

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The End of Fear-Based Medicine

"This marks a turning point in women's health. For years, outdated warnings kept women from life-saving treatment. Modern evidence is clear. When prescribed correctly, hormone therapy not only relieves symptoms but significantly reduces risks for many women."
- Dr. Lorna A. Brudie, Fem Excel

At Fem Excel, we will keep doing what we have always done: advocate for women, follow the science, and deliver high-touch, individualized care. We don't just manage women's health. We restore it. 

The era of fear is over. The era of informed choice belongs to you.

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Take Control of Your Health

"This marks a turning point in women's health. For years, outdated warnings kept women from life-saving treatment. Modern evidence is clear. When prescribed correctly, hormone therapy not only relieves symptoms... it significantly reduces risks for many women."

Dr. Lorna A. Brudie, Fem Excel

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References:

1. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368. doi:10.1001/jama.2013.278040.
   https://jamanetwork.com/journals/jama/fullarticle/1745676
   
2. Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011. doi:10.1210/jc.2015-2236.
   https://academic.oup.com/jcem/article/100/11/3975/2836060
   
3. Hodis HN, Mack WJ, Henderson VW, et al. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231. doi:10.1056/NEJMoa1505241.
   https://www.nejm.org/doi/full/10.1056/NEJMoa1505241
   
4. 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;318(10):927-938. doi:10.1001/jama.2017.11217.
   https://jamanetwork.com/journals/jama/fullarticle/2653735
   
5. Davis SR, Baber R, Panay N, et al. Hormone therapy in menopause. Endocr Rev. 2021;42(6):720-752. doi:10.1210/endrev/bnab011.
   https://academic.oup.com/edrv/article/42/6/720/6365992
   
6. Cho L, Kibbe M, Mansour M, et al. Rethinking menopausal hormone therapy: For whom, what, when. Circulation. 2023;147(21):1616-1635. doi:10.1161/CIRCULATIONAHA.122.061559.
   https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.061559
   
7. Lee SR, Cho MK, Kim SH, et al. The 2020 Menopausal Hormone Therapy Guidelines. J Menopausal Med. 2020;26(2):69-98. doi:10.6118/jmm.20011.
   https://pmc.ncbi.nlm.nih.gov/articles/PMC7475284/
   
8. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: Nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810. doi:10.1136/bmj.k4810.
   https://www.bmj.com/content/364/bmj.k4810

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