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] — ConclusionResources 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-therapyHHA 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 Therapyhttps://jamanetwork.com/journals/jama/fullarticle/2841321Book The New Menopause by Dr Mary Claire Haver MDDr Rachel Rubin’s Education Resources for Clinicians and Patients: https://www.rachelrubinmd.com/educationThe Menopause Society website, includes Practitioner Directoryhttps://menopause.org/🎧 Connect & Share:Have questions or want to connect?👉 Subscribe on YouTube:The Pelvic Connection with Laura McKaig PThttps://www.youtube.com/channel/UCE7zyN28inZxCovuMqInzSA👉 Follow on Facebook:https://www.facebook.com/lauramckaigpt/👉 Follow on Instagram:

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