Unboxing the Black Box: What the FDA’s Label Change Means for Menopause Care

Unboxing the Black Box: The FDA has removed or revised the boxed warnings on many estrogen-containing menopause therapies, but what does that actually mean?

In this episode, I explain what a black boxed warning is, why it was applied decades ago, why newer evidence shows the situation is more nuanced, especially for low-dose vaginal estrogen, and what the label change means for people in perimenopause and menopause. Links to FDA, HHS, and JAMA commentary in the episode notes below.

⏱️ Timestamps:

[00:00] — Major Change in Women's Health

[01:27] — FDA's Black Box Warning Removal

[02:04] — Understanding the Black Box Warning

[03:04] — Personal Prescription Example

[04:00] — What is a Black Box Warning?

[05:49] — Detailed Breakdown of the Black Box Warning

[11:43] — The Women's Health Initiative Study

[13:34] — Media's Role in Spreading Misinformation

[15:33] — Scientific and Advocacy Groups' Response

[16:36] — Key Factors in Reversing the Black Box Warning

[23:22] — The Unboxing Menopause Campaign

[24:45] — FDA's Official Announcement

[25:52] — Impact on Perimenopausal and Postmenopausal Women

[26:21] — Challenges in Accessing Hormone Therapy

[27:18] — Dr. Rachel Rubin's Personal Story

[30:00] — The Importance of Advocacy

[31:57] — Steps to Advocate for Yourself

[32:56] — Resources for Hormone Replacement Therapy

[36:47] — Client's Story: Empowerment Through Advocacy

[40:15] — Encouraging Conversations and Education

[41:15] — Conclusion

Resources and Readings:

FDA announcement and fact sheet on the label changes:

https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

HHA press announcement and fact sheet on the removal of black box warnings:

https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html

JAMA article Nov 10 2025, Updated Labeling for Menopausal Hormone Therapy

https://jamanetwork.com/journals/jama/fullarticle/2841321

Book The New Menopause by Dr Mary Claire Haver MD

Dr Rachel Rubin’s Education Resources for Clinicians and Patients:

https://www.rachelrubinmd.com/education

The Menopause Society website, includes Practitioner Directory

https://menopause.org/

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