FDA removal of HRT black box warning

Dr. Lauren Spivack is a board-certified OB-GYN, Menopause Society Certified Practitioner, and fellowship-trained minimally invasive gynecologic surgeon. She treats patients in South Jersey and through the evidence-based telehealth platform Alloy (https://www.myalloy.com/). In this episode, we break down the Women's Health Initiative, the FDA's 2025 removal of the black box warning from estrogen products, the newly named musculoskeletal syndrome of menopause, testosterone in women, and why the formulation you choose matters more than most providers realize.

What We Discuss:

00:00 HRT Timing Window

00:25 Meet the Hosts

01:19 Dr Spivack Background

02:47 Pelvic Pain to Menopause

03:34 Menopause Care Gaps

09:19 Defining Menopause Stages

11:01 WHI Study Breakdown

19:37 Why Age Matters

21:59 Recognizing Symptoms

25:32 Musculoskeletal Links

27:57 Team Based Referrals

31:33 FDA Label Update

34:23 Bioidentical vs Compounded

36:51 Vaginal Estrogen GSM

39:43 Systemic Options and Risks

45:54 Dosing and Expectations

46:57 HRT Starting Doses

48:08 Progesterone Dosing Basics

48:53 Perimenopause and HRT

51:16 Breast Cancer Risk Talk

55:12 When HRT Is Not Right

58:39 Lifestyle and Sleep Focus

01:01:46 Progesterone Only Option

01:03:04 Testosterone for Women

01:07:13 Labs and Monitoring

01:11:56 HRT Hype and Telehealth

01:20:51 Overtreatment and Pellets

01:23:33 Fixing Menopause Care

01:26:25 Putting Health Back

01:28:43 Wrap Up and Disclaimer

Studies & Literature Mentioned:

• WHI Original Trial: Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women (https://pubmed.ncbi.nlm.nih.gov/12117397/) (Rossouw et al., JAMA 2002)

• WHI 30-Year Review: The Women's Health Initiative Randomized Trials and Clinical Practice (https://pubmed.ncbi.nlm.nih.gov/38691368/) (Manson et al., JAMA 2024)

• Musculoskeletal Syndrome of Menopause: The Musculoskeletal Syndrome of Menopause (https://pubmed.ncbi.nlm.nih.gov/39077777/) (Wright et al., Climacteric 2024)

• FDA Announcement: HHS Removes Misleading FDA Warnings on Hormone Replacement Therapy (https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy) (November 10, 2025)

• HHS Fact Sheet: FDA Initiates Removal of Black Box Warnings from MHT Products (https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html)

• Veozah (Fezolinetant): FDA Safety Communication on Liver Injury Risk (https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due)

Concepts & People:

• Dr. Vonda Wright (https://www.womensportsforummd.com/) — Orthopedic surgeon, lead author on the musculoskeletal syndrome of menopause paper

• Dr. Mary Claire Haver (https://thepauselife.com/) — OB-GYN, author of The New Menopause (NYT Bestseller)

• Dr. Lisa Mosconi (https://www.lisamosconi.com/) — Neuroscientist, Director of the Women's Brain Initiative at Weill Cornell, researching estrogen and Alzheimer's risk

• The Menopause Society (https://menopause.org/) — Professional organization and certified menopause provider directory

• Mark Cuban Cost Plus Drugs (https://www.costplusdrugs.com/) — Affordable medication option for uninsured patients

Connect with Dr. Spivack:

• Alloy Profile: Dr. Lauren Spivack (https://www.myalloy.com/expert/lauren-spivack)

• Virtua/Rowan Medicine: Provider Profile (https://doctors.virtua.org/provider/lauren-spivack/2136705)

• LinkedIn: Lauren Spivack, MD (https://www.linkedin.com/in/lauren-spivack-937b8210/)

Connect with Medicine Redefined:

• Website: medicineredefined.com

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• Newsletter: The Progress Note

Work with Dr. Raja:

• Refining Health & Performance: refininghealthrx.com

  • Dr. Raja's musculoskeletal and longevity practice (Telemedicine available in NJ, NY, PA, FL).