I Need Your Help: Tell the FDA They Are Wrong About Estrogen

[madman]

Rachel Rubin, MD a urologist and sexual medicine specialist, discusses the critical need for physician and public engagement with the FDA on women's health. Learn how to advocate for the removal of inaccurate boxed warning labels on vaginal hormone therapies.

Dr. Rubin highlights the immense benefits and safety of vaginal estrogen and DHEA for treating genitourinary syndrome of menopause (GSM). She explains how these local therapies can prevent serious conditions like urinary tract infections and improve sexual health, dispelling common misconceptions and emphasizing the lack of evidence supporting the current warning labels. This episode is a call to action for all healthcare professionals, including primary care physicians, cardiologists, and oncologists, to confidently prescribe these life-saving medications. Get involved and share your voice to help save lives and transform the future of women's health.

 

[madman]

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

Jul 17, 2025

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...

• madman
• menopause; hrt; estrogen; testosterone; health
• Replies: 16
• Forum: HRT in Women

 

[madman]

Thread 'New 2025 AUA Guideline: Dr. Rachel Rubin Shows How Low-Dose Vaginal Estrogen Prevents UTIs, Relieves GSM Symptoms, and Protects Women’s Health'

Oct 2, 2025

BOXED WARNING

Dr. Rachel Rubin

Dr. Rachel Rubin outlines how simple, low-dose vaginal estrogen—backed by the 2025 AUA GSM guideline—can prevent recurrent UTIs, relieve symptoms, and save lives. A must-watch for providers treating menopausal patients.

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

 

[madman]

Thread 'AUA Guidelines on Genitourinary Syndrome of Menopause (GSM)'

Nov 12, 2025

Rachel Rubin, MD

• madman
• gsm; estradiol; vaginal health; menopause
• Replies: 3
• Forum: HRT in Women

 

[madman]

Thread 'FDA Removes Black Box Warning: What the New HRT Guidelines Mean for Women’s Health and HRT'

Nov 15, 2025

Dr. Rachel Rubin and Dr. Kelly Caspersen discuss with FDA Commissioner Dr. Marty Makary the significant impact of hormone replacement therapy (HRT) on women's health, particularly in the context of recent FDA changes to black box warnings. They explore the misconceptions surrounding HRT, the importance of education for both clinicians and patients, and the long-term health benefits of hormone therapy. The discussion emphasizes the need for accurate labeling, comprehensive care, and empowering women to make informed choices about their health...

• madman
• hrt; estrogen; fda; black box; women's health
• Replies: 3
• Forum: HRT in Women

 

[madman]

Thread 'Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy'

Nov 23, 2025

FDA Commissioner and subject matter experts from the Center for Drug Evaluation and Research discuss the agency's recent announcement regarding removal of the “black box warning” for hormone replacement therapy.








Proposed Changes Related to Safety Information Labeling

Proposed Changes for All MHTs (Systemic and Local Vaginal Products)

Additional Proposed Changes for Systemic Products

Additional Proposed Changes for Local Vaginal Estrogen Products

• madman
• menopause; hrt; estrogen; fda/black box
• Replies: 2
• Forum: HRT in Women

 

[madman]

Thread 'Menopause, Estrogen & the FDA: What Experts Say Needs to Change'

Dec 9, 2025

The FDA just held a hearing on menopause—and experts say it’s time to rethink hormone labels. Dr. James Simon joins Fempower Health to explain what needs to change and what it means for women.




Chapters:

00:00 Intro – Why This Conversation Matters
00:14 Why Estrogen Labels Matter
00:20 Testosterone: The Missing Option for Women
06:31 Vaginal Estrogen: Creams, Rings & Pills
18:18 Breast Cancer, BRCA & Safety
26:47 Why Experts Say No New Studies Are Needed
30:07 Georgie’s Story: Vaginal...

• madman
• menopause; estrogen; fda; women's health
• Replies: 1
• Forum: HRT in Women

 

[madman]

Thread 'Redefining Menopause: Your Guide to Hormonal Harmony'

Dec 28, 2025

This session, hosted by Dr. Rachel Rubin, a leading Urologist and sexual medicine specialist, and Heather Florio, CEO of Desert Harvest, explores the intersection of hormonal health, sexual wellness, and interstitial cystitis (IC).

Together, they’ll redefine what menopause means today — addressing common misconceptions, sharing evidence-based strategies for hormonal balance, and providing practical insights to improve your quality of life. Whether you’re currently experiencing menopause, approaching it, or supporting someone who is, this...

• madman
• menopause/gsm; vaginal estrogen; hrt; fda
• Replies: 1
• Forum: HRT in Women