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.
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...
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
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
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...