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FDA Removes Black Box Warning on Hormone Therapy for Menopause: What Charlotte Women Need to Know | Nova Transformations

FDA Removes Black Box Warning on Hormone Therapy for Menopause: What Charlotte Women Need to Know | Nova Transformations

FDA Removes Black Box Warning on Hormone Therapy for Menopause: What Charlotte Women Need to Know | Nova Transformations
🔴 BREAKING NEWS – November 10, 2025

FDA Removes Black Box Warning on Hormone Replacement Therapy for Menopause: What Charlotte Women Need to Know

Published: November 11, 2025 Category: Women’s Health News Location: Charlotte, NC Reading Time: 20 minutes

In a historic decision announced November 10, 2025, the U.S. Food and Drug Administration (FDA) is removing the “black box” warning from hormone replacement therapy (HRT) products used to treat menopause symptoms—reversing 23 years of guidance that discouraged millions of women from accessing this treatment. FDA Commissioner Dr. Marty Makary called the decades-long fear surrounding HRT “an American tragedy” and “one of the biggest mistakes in modern medicine,” stating that 50-70 million women have been denied “life-changing, life-saving benefits” due to outdated warnings based on misinterpreted science. The announcement, made at a press conference attended by Second Lady Usha Vance and over 200 people, represents a seismic shift in women’s healthcare that will affect the approximately 2 million American women who enter menopause each year.

At Nova Transformations in Charlotte, North Carolina, we recognize that menopause and perimenopause profoundly affect mental health, relationships, and quality of life. Many women we serve at our dual diagnosis treatment center struggle with depression, anxiety, mood swings, and emotional dysregulation connected to hormonal changes—symptoms that hormone therapy can significantly improve. This FDA decision is monumental because it gives women back control over their bodies and healthcare decisions, ending years of fearmongering that prevented informed conversations between women and their doctors. Commissioner Makary emphasized: “With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy.”

This comprehensive guide explains what the FDA announced, why the black box warning was removed, the proven benefits of hormone replacement therapy, who should consider it, risks that remain, the critical mental health connection, and resources for Charlotte women navigating this transition.

50-70M

Women denied hormone replacement therapy over 23 years due to misinterpreted black box warnings

What Did the FDA Announce?

The Historic Decision

On November 10, 2025, the FDA announced it is initiating removal of “black box” warnings from hormone replacement therapy products for menopause.

Specific changes:

  • Removing warnings about: Cardiovascular disease (heart attacks, strokes), breast cancer, and probable dementia
  • Keeping warning for: Endometrial cancer for estrogen-alone products (women without a uterus)
  • Adding recommendation: Start HRT in women younger than 60 or within 10 years of menopause onset
  • Updating labels: Manufacturers will reprint product labeling; risks will still appear in package inserts with appropriate nuance

Types of Hormone Therapy Affected

All forms of HRT had black box warnings—all are being updated:

  • Pills (oral estrogen)
  • Patches (transdermal estrogen)
  • Creams and gels (topical estrogen)
  • Vaginal estrogen (low-dose for local symptoms)
  • Combined estrogen + progesterone products

Additional FDA Actions

Along with removing black box warnings, the FDA also:

  • Approved first generic Premarin (conjugated estrogens) in 30+ years—improving affordability
  • Approved new non-hormonal treatment for moderate to severe hot flashes for women who can’t/won’t use hormones

Key Quotes from the Announcement

HHS Secretary Robert F. Kennedy Jr.: “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”

FDA Commissioner Dr. Marty Makary: “Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk. For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”

80%

Of women experience menopause symptoms—lasting an average of 8 years, often severe or debilitating

Why Was There a Black Box Warning in the First Place?

The 2002 Women’s Health Initiative Study

In 2002, a large government study called the Women’s Health Initiative (WHI) reported findings that shocked the medical world:

  • Hormone therapy appeared to increase risk of:
    • Breast cancer
    • Heart disease and heart attacks
    • Blood clots
    • Strokes
    • Dementia
  • Media coverage was alarming: Headlines screamed about dangers
  • Doctors panicked: Millions of women were immediately taken off HRT
  • FDA added black box warning in 2003: The agency’s strongest warning label

The Result: 23 Years of Fear

  • HRT use plummeted: From widespread use to doctors refusing to prescribe
  • Women suffered needlessly: Severe menopause symptoms went untreated
  • Medical “groupthink”: Doctors were taught HRT was dangerous
  • Stigma developed: Women ashamed to ask about HRT
  • Commissioner Makary: “It’s an American tragedy. I do think it’s one of the biggest mistakes in modern medicine.”

What Was Wrong With the Study?

Subsequent analysis revealed major problems with how the WHI data was interpreted:

  1. Study population was wrong: Women in the study averaged age 63—most were 10+ years past menopause. This is NOT when HRT is typically started.
  2. Timing matters enormously: Starting HRT within 10 years of menopause (ages 50-60) shows BENEFITS for cardiovascular health. Starting after age 60 when blood vessels have already hardened shows risks.
  3. Statistical significance overstated: The breast cancer increase was “statistically non-significant” but reported as significant
  4. Absolute vs. relative risk confused: Small absolute increases presented as large relative risks
  5. Benefits ignored: Significant reductions in bone fractures, diabetes, colorectal cancer not emphasized
  6. Type of HRT mattered: Study used one specific formulation (Prempro) not representative of all HRT

FDA Commissioner Makary: The warning was based on “a medical dogma rooted in a distortion of risk.”

The Expert Panel Process

  • July 2025: FDA convened expert panel to review HRT warnings
  • Public comment period: Nearly 3,000 comments received—overwhelmingly supporting removal
  • Expert consensus: Panels reviewed latest science showing HRT benefits outweigh risks for appropriate candidates
  • Decision: Remove misleading warnings, update with accurate risk information

The Proven Benefits of Hormone Replacement Therapy

Modern research shows HRT, when started at the right time, provides remarkable health benefits:

1. Cardiovascular Protection

  • Reduces heart attack risk when started within 10 years of menopause
  • Heart disease is #1 killer of women—HRT can prevent this
  • Improves cholesterol profiles
  • Maintains blood vessel elasticity
  • Reduces arterial stiffening

Commissioner Makary: HRT “may improve the health outcomes of women at a population level more than any other intervention, arguably, with the exception of, say, antibiotics or vaccines.”

2. Bone Health

  • Reduces risk of bone fractures by 50-60% (New England Journal study)
  • Prevents osteoporosis
  • Maintains bone density
  • Reduces hip fractures—which are life-threatening in elderly women

3. Cognitive Protection

  • Reduces cognitive decline by up to 64%
  • Reduces Alzheimer’s risk by 35% in one study
  • Protects brain health when started early
  • Note: Benefits only seen when started within 10 years of menopause—not later

4. Menopause Symptom Relief

Most effective treatment for:

  • Hot flashes: 80-90% reduction
  • Night sweats: Dramatic improvement
  • Vaginal dryness: Complete resolution with vaginal estrogen
  • Painful intercourse: Significantly improved
  • Urinary tract infections: Reduced frequency
  • Sleep disturbances: Better sleep quality

5. Mental Health Benefits

This is critical for our work at Nova Transformations:

  • Reduces depression and anxiety related to hormonal changes
  • Stabilizes mood swings
  • Improves emotional regulation
  • Reduces irritability and anger
  • Improves concentration and mental clarity (“brain fog”)
  • Enhances overall quality of life

6. Other Benefits

  • Reduces risk of type 2 diabetes
  • Reduces colorectal cancer risk
  • Maintains skin elasticity
  • Prevents muscle loss
  • Improves sexual function and libido
  • Reduces joint pain

✨ The Bottom Line on Benefits

When started at the right time (within 10 years of menopause, generally before age 60), hormone replacement therapy significantly reduces risk of the leading causes of death and disability in women: heart disease, bone fractures, and cognitive decline—while dramatically improving quality of life.

Who Should Consider Hormone Replacement Therapy?

Ideal Candidates

HRT is most beneficial for women who:

  • Are experiencing bothersome menopause symptoms (hot flashes, night sweats, mood changes, vaginal dryness)
  • Are within 10 years of menopause onset
  • Are younger than age 60
  • Have no contraindications (see below)
  • Want to reduce long-term health risks (heart disease, osteoporosis, dementia)

Dr. Steven Fleischman (American College of Obstetricians and Gynecologists): “The vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy.”

The “10-Year Window”

Critical timing principle:

  • Start HRT within 10 years of menopause onset
  • Or before age 60
  • Why: Blood vessels are still healthy, flexible, and can benefit from estrogen
  • After age 60: Vessels have hardened, estrogen may not help or could increase risks

Who Should NOT Take HRT

Contraindications (reasons not to use):

  • Active breast cancer or history of breast cancer (in most cases)
  • History of blood clots (DVT, pulmonary embolism)
  • History of stroke
  • Active liver disease
  • Unexplained vaginal bleeding
  • Pregnancy
  • Known or suspected estrogen-sensitive cancer

Special Considerations

Women with a uterus:

  • Must take estrogen PLUS progesterone
  • Progesterone protects uterine lining from overgrowth
  • Reduces endometrial cancer risk

Women who’ve had hysterectomy:

  • Can take estrogen alone
  • No need for progesterone
  • Simpler regimen

Understanding the Risks (That Still Exist)

Important: Black box warning removed ≠ no risks. HRT still has risks—they’re just much smaller and more nuanced than the old warning suggested.

Remaining Risks

1. Blood Clots

  • Small increased risk, especially with oral estrogen
  • Transdermal (patch/gel) estrogen has lower clot risk
  • Risk highest in first year of use
  • Higher risk if personal/family history of clots

2. Breast Cancer

  • Small increase in risk with long-term use (>5 years)
  • Estrogen alone may NOT increase risk
  • Combined estrogen + progesterone has slightly higher risk
  • Risk similar to that from obesity, alcohol use, or delayed childbearing
  • Absolute risk remains low

3. Endometrial Cancer

  • Risk only with estrogen alone in women with a uterus
  • Adding progesterone eliminates this risk
  • Black box warning KEPT for estrogen-alone products

4. Stroke

  • Small increased risk, especially after age 60
  • Lower risk when started younger/closer to menopause
  • Transdermal estrogen may have lower stroke risk

Comparing Risks

To put HRT risks in perspective:

Risk Factor Breast Cancer Risk Increase
HRT (5-10 years) Small increase (similar to below)
Being overweight/obese Similar or higher
Drinking 2+ alcoholic drinks daily Similar or higher
Never having children Similar
Smoking Higher

The Risk-Benefit Calculation

For most women within the 10-year window:

  • Benefits significantly outweigh risks
  • Reduced mortality from heart disease and fractures > small cancer risk
  • Quality of life improvements are substantial
  • Individual risk factors must be considered

💡 Individualized Decision-Making

Every woman is different. The decision to use HRT should be made with your doctor based on YOUR personal health history, risk factors, symptoms, and preferences. The FDA’s action simply removes barriers to having that informed conversation—it doesn’t mean every woman should or must take HRT.

The Mental Health Connection: Why This Matters at Nova Transformations

At Nova Transformations in Charlotte, we treat many women struggling with depression, anxiety, mood disorders, and substance use—and hormonal changes are often a significant contributing factor.

Menopause and Mental Health

The dramatic hormonal shifts during perimenopause and menopause profoundly affect brain chemistry and mental health:

Common Mental Health Symptoms:

  • Depression: New onset or worsening
  • Anxiety: Panic attacks, generalized anxiety
  • Mood swings: Rapid emotional changes
  • Irritability and anger: “Rage” episodes
  • Brain fog: Difficulty concentrating, memory problems
  • Emotional dysregulation: Feeling out of control
  • Sleep disturbances: Insomnia worsening mood
  • Relationship problems: Strain on marriage, family
  • Loss of identity: Feeling like “I’m not myself”

FDA Commissioner Makary: Symptoms “occur in over 80% of women. They last, on average, eight years. And for many women, they are severe, even debilitating: mood swings, night sweats, weight gain, hot flashes, divorce.”

When Menopause Mimics or Worsens Mental Illness

  • Women misdiagnosed with new-onset mental illness when it’s actually hormonal
  • Existing depression/anxiety worsens during perimenopause
  • Increased risk of suicidal ideation during menopause transition
  • Some women self-medicate with alcohol or substances

How HRT Helps Mental Health

Hormone replacement therapy can significantly improve:

  • Mood stability: Reduces depression and anxiety symptoms
  • Emotional regulation: Less reactive, more balanced
  • Cognitive function: Clearer thinking, better memory
  • Sleep quality: Which improves everything else
  • Quality of life: Feeling like yourself again
  • Relationships: Less conflict, better communication

Integrated Treatment Approach

At Nova Transformations, we recognize that effective mental health treatment for women in perimenopause/menopause often requires:

  1. Psychiatric medication: Antidepressants, anti-anxiety meds as needed
  2. Psychotherapy: CBT, DBT, trauma therapy
  3. Hormone optimization: Working with gynecologist/endocrinologist
  4. Lifestyle interventions: Exercise, nutrition, sleep hygiene, stress management
  5. Support systems: Group therapy, family involvement

This FDA decision means women can now access ALL these tools without the stigma and fear that prevented HRT for two decades.

✨ You’re Not “Going Crazy”

If you’re experiencing depression, anxiety, mood swings, or feeling unlike yourself during your 40s-50s, you’re not imagining it and you’re not weak. Hormonal changes cause real, significant mental health symptoms. Treatment is available and effective. You deserve to feel like yourself again.

What Charlotte Women Should Do Now

1. Talk to Your Doctor

  • Schedule appointment with gynecologist or primary care doctor
  • Discuss symptoms you’re experiencing
  • Ask about HRT: “Am I a candidate for hormone replacement therapy?”
  • Understand options: Pills, patches, creams—which is best for you?
  • Discuss risks/benefits based on YOUR health history

2. Don’t Wait

  • If you’re within the 10-year window, now is the time to consider HRT
  • Benefits are greatest when started early in menopause transition
  • Suffering through severe symptoms is no longer necessary

3. Address Mental Health Concurrently

4. Get Support

  • Join menopause support groups
  • Connect with other women going through this transition
  • Don’t suffer in silence

Mental Health Support for Women in Charlotte

If you’re struggling with depression, anxiety, mood swings, or emotional challenges during perimenopause or menopause, Nova Transformations can help. Our comprehensive mental health programs address the complex interplay between hormones, brain chemistry, life stressors, and emotional wellbeing. We provide evidence-based therapy, medication management when needed, and compassionate support as you navigate this transition. You don’t have to suffer—effective treatment is available.

We accept most major insurance plans. Unfortunately, we do not accept Medicare or Medicaid at this time.

Confidential assessment. Day and evening programs available. You deserve to feel like yourself again.

Frequently Asked Questions

Why did the FDA remove the black box warning on hormone replacement therapy?

The FDA removed the black box warning from hormone replacement therapy (HRT) for menopause on November 10, 2025, after determining that 23 years of warnings were based on misinterpreted science from a 2002 Women’s Health Initiative study that has been extensively re-analyzed and found to have significant methodological problems. The original study included women averaging age 63 who were 10+ years past menopause—NOT the population that typically uses HRT—and subsequent research has shown that when HRT is started at the appropriate time (within 10 years of menopause, generally before age 60), the benefits significantly outweigh risks. FDA Commissioner Dr. Marty Makary stated that “50 to 70 million women over the last 23 years have been denied the incredible, life-changing, life-saving benefits of hormone replacement therapy because of the dogma” created by the black box warning. An expert panel convened in July 2025 reviewed modern evidence showing HRT reduces heart disease (the #1 killer of women), bone fractures by 50-60%, cognitive decline by up to 64%, and Alzheimer’s risk by 35% while being the most effective treatment for menopause symptoms like hot flashes, mood swings, and vaginal dryness. The agency emphasized that “with the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy.” The black box warning created a “fear machine” that prevented informed conversations between women and doctors, leading to unnecessary suffering. While HRT still has risks that will be detailed in updated package inserts including small increases in blood clots and breast cancer with long-term use, these risks are far smaller than the old warning suggested and similar to risks from obesity, alcohol consumption, or never having children. The FDA’s action returns decision-making to women and their doctors based on accurate, evidence-based information rather than fear. The agency is keeping the warning for endometrial cancer for estrogen-alone products in women with a uterus.

What are the benefits of hormone replacement therapy for menopause?

Hormone replacement therapy (HRT) for menopause provides extensive health benefits when started at the right time—within 10 years of menopause onset or before age 60—that have been obscured by 23 years of black box warnings. Cardiovascular protection is significant with HRT reducing heart attack risk, improving cholesterol profiles, maintaining blood vessel elasticity, and preventing arterial stiffening, which is critical since heart disease is the leading cause of death in women. For bone health, HRT reduces the risk of fractures by 50-60% according to New England Journal studies, prevents osteoporosis, maintains bone density, and significantly reduces life-threatening hip fractures in elderly women. Cognitive benefits include reducing cognitive decline by up to 64%, lowering Alzheimer’s risk by 35% in studies, and protecting brain health when started early in the menopause transition—though these benefits are only seen when HRT begins within 10 years of menopause, not later. For menopause symptom relief, HRT is the most effective treatment providing 80-90% reduction in hot flashes, dramatic improvement in night sweats, complete resolution of vaginal dryness (especially with vaginal estrogen), significant improvement in painful intercourse, reduced urinary tract infections, and better sleep quality. Mental health benefits are substantial including reduced depression and anxiety related to hormonal changes, stabilized mood swings, improved emotional regulation, reduced irritability and anger, enhanced concentration and elimination of “brain fog,” and dramatically improved overall quality of life. Additional benefits include reduced risk of type 2 diabetes, lower colorectal cancer risk, maintained skin elasticity, prevention of muscle loss, improved sexual function and libido, and reduced joint pain. FDA Commissioner Makary emphasized that HRT “may improve the health outcomes of women at a population level more than any other intervention, arguably, with the exception of, say, antibiotics or vaccines.” The key is timing—these benefits are greatest when HRT is started during the menopausal transition, not years later.

Is hormone replacement therapy safe now that the FDA removed the warning?

Hormone replacement therapy (HRT) is safe for the vast majority of women when used appropriately, but removal of the black box warning does NOT mean there are no risks—it means the risks are much smaller and more nuanced than the old warning suggested, and for most women within the appropriate treatment window, benefits significantly outweigh risks. Remaining risks include a small increased risk of blood clots especially with oral estrogen (transdermal patches/gels have lower risk) with risk highest in the first year of use, small increase in breast cancer risk with long-term use exceeding 5 years particularly with combined estrogen plus progesterone (though absolute risk remains low and similar to that from obesity or alcohol use), endometrial cancer risk only with estrogen alone in women with a uterus which is eliminated by adding progesterone, and small increased stroke risk especially after age 60 (lower when started younger/closer to menopause). To put these risks in perspective, the breast cancer risk increase from HRT is similar to or lower than risks from being overweight, drinking 2+ alcoholic drinks daily, or never having children. The critical safety principle is the “10-year window”—HRT is safest and most beneficial when started within 10 years of menopause onset or before age 60 when blood vessels are still healthy and can benefit from estrogen, whereas starting after age 60 when vessels have hardened may not provide cardiovascular benefits and could increase certain risks. HRT should NOT be used by women with active or history of breast cancer (in most cases), history of blood clots, history of stroke, active liver disease, unexplained vaginal bleeding, pregnancy, or estrogen-sensitive cancers. Dr. Steven Fleischman from the American College of Obstetricians and Gynecologists stated “the vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy.” The FDA’s action means women can now have informed conversations with their doctors about whether HRT is appropriate based on their individual health history, symptoms, and preferences without an outdated warning creating unnecessary fear. Like all medications, HRT requires individualized risk-benefit assessment—it’s not right for everyone, but it’s safe and beneficial for most women when used correctly.

How does menopause affect mental health and can hormone therapy help?

Menopause profoundly affects mental health due to dramatic hormonal shifts that alter brain chemistry, and hormone replacement therapy (HRT) can significantly improve mental health symptoms when they’re hormonally driven. The perimenopause and menopause transition causes common mental health symptoms including new-onset depression or worsening of existing depression, anxiety and panic attacks, rapid mood swings and emotional instability, severe irritability and “rage” episodes, brain fog with difficulty concentrating and memory problems, emotional dysregulation and feeling out of control, sleep disturbances from night sweats that worsen mood, relationship strain on marriages and family connections, and loss of identity with women feeling “I’m not myself anymore.” FDA Commissioner Makary noted these symptoms “occur in over 80% of women. They last, on average, eight years. And for many women, they are severe, even debilitating: mood swings, night sweats, weight gain, hot flashes, divorce.” Women are often misdiagnosed with new mental illness when symptoms are actually hormonal, existing psychiatric conditions worsen during the menopause transition, there’s increased risk of suicidal ideation during this period, and some women self-medicate with alcohol or substances leading to substance use disorders. At Nova Transformations in Charlotte, we treat many women whose depression, anxiety, and mood disorders are significantly connected to hormonal changes. HRT can dramatically improve mental health by stabilizing mood and reducing depression/anxiety symptoms, improving emotional regulation so women are less reactive and more balanced, enhancing cognitive function with clearer thinking and better memory, improving sleep quality which benefits all other aspects of mental health, dramatically improving quality of life and sense of wellbeing, and reducing relationship conflict with better communication. However, effective treatment often requires an integrated approach combining HRT with psychiatric medication (antidepressants, anti-anxiety medications) when needed, evidence-based psychotherapy like CBT or DBT, lifestyle interventions including exercise and stress management, and strong support systems. The FDA’s removal of the black box warning means women can now access HRT as part of comprehensive mental health treatment without the stigma and fear that prevented this for 23 years. If you’re experiencing mental health struggles during your 40s-50s, you’re not “going crazy”—hormonal changes cause real symptoms, and effective treatment is available.

What should women in Charlotte do about hormone replacement therapy after this FDA announcement?

Charlotte women should take several important steps following the FDA’s November 10, 2025 announcement removing black box warnings from hormone replacement therapy. First, schedule an appointment with your gynecologist or primary care doctor to discuss whether you’re experiencing menopause symptoms like hot flashes, night sweats, mood changes, vaginal dryness, or sleep disturbances, ask directly “Am I a candidate for hormone replacement therapy?”, understand different HRT options including pills, patches, creams, and which is best for your situation, and have a thorough conversation about risks and benefits based on YOUR specific health history and risk factors. Don’t wait if you’re within the critical “10-year window”—the time to consider HRT is within 10 years of menopause onset or before age 60 when benefits are greatest, suffering through severe symptoms is no longer necessary now that outdated warnings have been removed, and delaying could mean missing the optimal treatment window. Address mental health concerns concurrently because if you’re experiencing depression, anxiety, mood swings, irritability, or feeling unlike yourself, these symptoms may be hormonally driven and require professional treatment—Nova Transformations in Charlotte offers comprehensive mental health programs including Intensive Outpatient and Partial Hospitalization Programs, individual and group therapy, psychiatric medication management, and dual diagnosis treatment addressing both mental health and any co-occurring conditions. Get support by joining menopause support groups, connecting with other women navigating this transition, and refusing to suffer in silence as millions have done for 23 years. Educate yourself using reliable sources about HRT benefits and risks so you can make informed decisions with your doctor. If your doctor is hesitant about HRT due to outdated training from the black box warning era, share the FDA’s November 2025 announcement and consider seeking a second opinion from a menopause specialist or gynecologist current with latest evidence. The key message is that you have options now—effective treatment is available without stigma or unnecessary fear, and you deserve to feel like yourself again with optimal health throughout the menopause transition and beyond. Call Nova Transformations at (704) 961-9322 if you need mental health support during this life transition.

References and Resources

  1. U.S. Food and Drug Administration. (2025, November 10). HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. FDA Press Release. Retrieved from https://www.fda.gov/
  2. U.S. Department of Health and Human Services. (2025, November 10). HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. HHS.gov. Retrieved from https://www.hhs.gov/
  3. Park, A. (2025, November 10). FDA Removes Black Box Warning on Hormone Therapy. TIME. Retrieved from https://time.com/
  4. ABC News. (2025, November 10). FDA removes ‘black box’ warning label on hormone replacement therapy for menopause. Retrieved from https://abcnews.go.com/
  5. National Public Radio (NPR). (2025, November 10). FDA reverses decades of guidance on hormone therapy for menopause. Retrieved from https://www.npr.org/
  6. NBC News. (2025, November 10). Hormone replacement therapy will no longer carry a warning label, FDA says. Retrieved from https://www.nbcnews.com/
  7. CBS News. (2025, November 10). FDA chief says warning labels deterred women from using menopause hormone therapy: “It’s an American tragedy.” Retrieved from https://www.cbsnews.com/
  8. The Washington Post. (2025, November 10). Hormone replacement therapy for menopause could become easier to access. Retrieved from https://www.washingtonpost.com/
  9. The New York Times. (2025, November 10). F.D.A. Removes Warning on Menopause Hormone Therapy. Retrieved from https://www.nytimes.com/
  10. The North American Menopause Society (NAMS). (2024). The 2024 Hormone Therapy Position Statement. Menopause Journal.

Charlotte Women’s Health Resources:

  • Nova Transformations (Mental Health): (704) 961-9322
  • Atrium Health Women’s Services: Charlotte-area OB/GYN care
  • Novant Health Women’s Health: Charlotte women’s healthcare
  • North American Menopause Society: Find menopause specialist at menopause.org

Medical Disclaimer: This article is for informational and educational purposes only and should not replace professional medical advice, diagnosis, or treatment. The FDA’s removal of black box warnings does not mean hormone replacement therapy is right for every woman or without risks. All medical decisions should be made in consultation with qualified healthcare providers based on individual health history, risk factors, and circumstances. Always consult your doctor before starting, stopping, or changing any medication or treatment. If experiencing medical or mental health emergencies, call 911 immediately.

Last Updated: November 11, 2025 | Author: Nova Transformations Clinical Team | Location: Charlotte, North Carolina | BREAKING NEWS

FDA Removes Black Box Warning on Hormone Therapy for Menopause: What Charlotte Women Need to Know | Nova Transformations
Nova Transformations, a leading addiction treatment center in Charlotte, North Carolina.

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