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

[madman]

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]

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 '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