S4 Ep189: The FDA Removes the Black Box Label for Hormone Therapy

In case you missed it, last week was quite the week in the menopause world. The FDA made a landmark decision to remove all black box warnings from estrogen products and to update the labels of individual products. I was in the room where it all happened and in this episode, I’m going to break it all down for you. But here’s the headline- this label change is overall, a good thing, a very good thing. A transcript of this podcast, along with photos and graphics, can be found on DrStreicher.Substack.com In this episode:  A historical perspective of how the Black Box label came to be on all estrogen products A review of the Women’s Health Initiative Study  (WHI) that lead to the specific warnings on the label.  The fall out from the release of the WHI The Problems with the Black Box label on estrogen products Class Labeling The difference between oral, transdermal and local vaginal estrogen.  How the required black box label influenced the likelihood of physicians writing a prescription for estrogen, and the likelihood that women would use hormone therapy.  Why I never stopped prescribing estrogen Last week’s announcement from the FDA If it is medically appropriate to remove the black box warning from local vaginal estrogen If it is medically appropriate to remove the black box warning from systemic estrogen The inaccurate messaging during the FDA press conference The POLITICS  of WHY the FDA removed the Black Box warnings Related Podcasts:  Episode 124 All Hormones Are Not Created Equal with Dr. James Simon Episode 164 Is Bioidentical Always Best? Episode 181 The FDA Roundtable on Menopausal Hormone Therapy Related Substack Articles Top 20 Questions about Local Vaginal Estrogen Is Bioidentical Always Best? BLOOD CLOTS and ESTROGEN: The Facts Crises at the FDA Why RFK is a Scary Choice for HHS Dr. Streicher is on SUBSTACK      DrStreicher.Substack.com Articles Monthly newsletter All COME AGAIN podcast episodes Monthly News Flash Reports on recent research  Monthly Zoom Ask Me Anything Webinar    Information on Dr. Streicher's COME AGAIN Podcast- Sexuality and Orgasm     Lauren Streicher MD, is a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, the founding medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause, and a Senior Research Fellow of The Kinsey Institute, Indiana University. She is a certified menopause practitioner of The Menopause Society. S   Dr. Streicher is the medical correspondent for Chicago’s top-rated news program, the WGN Morning News, and has been seen on The Today Show, Good Morning America, The Oprah Winfrey Show, CNN, NPR, Dr. Radio, Nightline, Fox and Friends, The Steve Harvey Show, CBS This Morning, ABC News Now, NBCNightlyNews,20/20, and World News Tonight. She is an expert source for many magazines and serves on the medical advisory board of The Kinsey Institute, Self Magazine, and Prevention Magazine. She writes a regular column for The Ethel by AARP and Prevention Magazine.    LINKS Subscribe To Dr. Streicher’s Substack Information About the COME AGAIN Podcast Dr. Streicher’s CV and additional bio information To Find a Menopause Clinician and Other Resources  Glossary Of Medical Terminology Books by Lauren Streicher, MD    Slip Sliding Away: Turning Back the Clock on Your Vagina-A gynecologist’s guide to eliminating post-menopause dryness and pain Hot Flash Hell: A Gynecologist's Guide to Turning Down the Heat Sex Rx- Hormones, Health, and Your Best Sex Ever The Essential Guide to Hysterectomy                                        Dr. Streicher’s Inside Information podcast is for education and information and is not intended to replace medical advice from your personal healthcare clinician. Dr. Streicher disclaims liability for any medical outcomes that may occur because of applying methods suggested or discussed in this podcast.