FDA Expert Panel on Menopause and HRT Recommends Removing Black Box Labels

This was a very important meeting with top experts that are trying to change guidelines. This FDA panel recently recommended removing the warning (“black box”) labels on menopausal HRT, citing potential benefits like reduced heart attack and bone fracture risk—and arguing the warning discourages appropriate use.

FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women​

Hopefully, we will see progress in this field after the confusing and sometimes misleading conclusions of the WHI (“Women’s Health Initiative”), a large National Institutes of Health trial that started in 1991 involving over 160,000 postmenopausal U.S. women aged 50–79. The WHI conclusions completely halted HRT in most women.


Round table discussion 2 of my favourites in the field Dr. Rubin and Dr. Casperson!

Some well known names on the panel including Dr. Simon!




Rachel S. Rubin

Kelly Casperson

Join the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. We'll discuss treatments, education, and comprehensive care beyond symptom management.

 

Thread 'The WHI: A Focus on Hormone Therapy (aka Lies, Damn Lies, and Statistics)'

Jun 11, 2022

To launch the Newson Health Menopause Society, Professor James Simon delivers an in-depth analysis of the 2002 WHI study.

• madman
• hrt; whi; estradiol; pre-post menopause
• Replies: 28
• Forum: HRT in Women

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Thread 'Testosterone for Women | Dr. Kelly Casperson at FDA Menopause Hearing'

Jul 18, 2025

At the recent ‪@US_FDA‬ hearing on menopause and hormone therapy, Dr. Kelly Casperson addressed a critical gap in care: the absence of FDA-approved testosterone options for women. While testosterone is widely available and approved for men, women remain without regulated, evidence-based dosing — despite clear benefits.

In this 5-minute speech, Dr. Casperson highlights the science, the inequity, and why this matters for all genders.

• madman
• menopause; hrtl; testosterone; health
• Replies: 5
• Forum: HRT in Women

 

Thread 'What Really Happened at the FDA Menopause Panel'

Jul 24, 2025

The FDA finally held a hearing on menopause—and it was long overdue. Georgie Kovacs breaks down the powerful expert testimony, the systemic failures, and why this matters for every woman navigating midlife care.

In this grounded recap, you’ll learn:

• Why the FDA’s black box warning on vaginal estrogen may be misleading

• The difference between systemic and local hormone absorption—and why it matters

• How testosterone access for women remains limited despite clear clinical need

• What experts like Dr. James...

• madman
• menopause; hrt; fda; women's health
• Replies: 4
• Forum: HRT in Women

 

Thread 'Ashley Winter, MD, calls for label update on low-dose vaginal estrogen'

Jul 26, 2025

Ashley Winter, MD, calls for label update on low-dose vaginal estrogen

"We are not offering patients comprehensive management unless we consider hormone therapies," says Ashley G. Winter, MD.

www.urologytimes.com

"We are not offering patients comprehensive management unless we consider hormone therapies," says Ashley G. Winter, MD.

On July 17, 2025, a panel of experts convened by the FDA outlined the growing consensus that the boxed warning label on menopausal hormone therapies, particularly low-dose vaginal estrogen, is an outdated or inappropriate representation of the risks. This discussion came on the heels of a landmark development in urology—the...

• madman
• menopause/gsm; vaginal estrogen; hrt; fda
• Replies: 4
• Forum: HRT in Women

 

Thread 'Why Low-Dose Vaginal Estrogen is Safe: Debunking Menopause Myths and Fighting for Women's Health'

Jul 29, 2025

Is one outdated warning label standing between millions of women and safe, effective care? In this episode of BackTable Urology, Dr. Yahir Santiago-Lastra, a urologist specializing in female pelvic medicine and reconstructive surgery at UC San Diego, joins host Dr. Suzette Sutherland to discuss the black box warning on vaginal estrogen, its historical context, and the ongoing advocacy efforts to update outdated FDA guidelines.




SYNPOSIS

The conversation covers the importance of low-dose vaginal estrogen in treating genitourinary syndrome of...

• madman
• gsm; hrt; vaginal estrogen; fda
• Replies: 2
• Forum: HRT in Women

 

Thread 'Menopause: What Every Woman Should Know'

Aug 2, 2025

* Julie Spencer—an expert in women's health within the field of urology—delivers a comprehensive overview of menopause. She emphasizes the diverse and often under-recognized spectrum of symptoms, including hot flashes, sleep disturbances, mood swings, weight gain, joint pain, vaginal dryness, and painful intercourse. Many women experience delays in diagnosis and treatment, often seeing multiple providers before their symptoms are appropriately attributed to menopause.

Diane K. Newman, DNP, ANP-BC, FAAN, FAUNA, BCB-PMD, Adjunct...

• madman
• menopause; hrt; t/estradiol; women's health
• Replies: 3
• Forum: HRT in Women

 

Thread 'The need for FDA approved testosterone formulations for women: Urologists advocacy'

Aug 2, 2025

* Winter explained that for a hormone replacement therapy to receive FDA approval, it must demonstrate safety and appropriate pharmacokinetics—specifically, its ability to raise hormone levels. Unlike other drug approvals, efficacy data is not required, as there is broad clinical consensus that restoring essential hormone levels is critical to overall health.

Ashley Winter, MD, discusses testosterone therapy for women

Ashley G. Winter, MD, reflects on the need for FDA approved testosterone formulations in women, emphasizing that urologists are well-positioned to drive change in this space.

www.urologytimes.com

Ashley G. Winter, MD, reflects on the need for FDA approved testosterone...

• madman
• hypogonadism; hrt; menopause; women's health
• Replies: 2
• Forum: HRT in Women

 

Thread 'Estradiol & Testosterone Testing in Menopause: Why Inaccurate Hormone Lab Results Could Be Putting Your Health at Risk'

Aug 7, 2025

* The Centers for Disease Control and Prevention (CDC) has established a program to standardize and improve the measurement of steroid hormones, including E2 and T, using liquid chromatography-tandem MS (LC-MS/MS). In addition, the CDC has partnered to establish postmenopausal reference ranges for T and is developing reference intervals for E2. Minimizing some of the technical limitations of the current immunoassays and MS assays should provide better and more accurate assays for patient care.


* Equilibrium dialysis combined with a MS assay is...

• madman
• menopause; hrt; t/e2; testing/assays
• Replies: 2
• Forum: HRT in Women

 

Thread 'Genitourinary Syndrome of Menopause (GSM): Latest Guidelines, Treatments & Myths Debunked'

Friday at 10:44 AM

The guidelines are in and the myths are out. In this episode of the BackTable Podcast, Dr. Suzette Sutherland hosts Dr. Melissa Kaufman and Dr. Giulia Ippolito to discuss the new 2025 AUA/SUFU guidelines on genitourinary syndrome of menopause (GSM).



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SYNPOSIS

The doctors delve into what GSM is, its symptoms, and the new evidence-based clinical guidelines for screening, diagnosing, and treating this condition. The episode emphasizes shared decision-making, safe use of local low-dose vaginal estrogen, and addresses...

• madman
• gsm; estradiol; vaginal health; menopause
• Replies: 1
• Forum: HRT in Women