{"id":29564,"date":"2025-10-22T09:20:18","date_gmt":"2025-10-22T07:20:18","guid":{"rendered":"https:\/\/www.neolifesalud.com\/blog\/uncategorized\/the-fda-reconsiders-its-warnings-on-hormone-therapy-in-menopause-the-beginning-of-a-new-era-for-womens-health\/"},"modified":"2025-10-22T09:20:18","modified_gmt":"2025-10-22T07:20:18","slug":"the-fda-reconsiders-its-warnings-on-hormone-therapy-in-menopause-the-beginning-of-a-new-era-for-womens-health","status":"publish","type":"post","link":"https:\/\/www.neolifesalud.com\/en\/blog\/hormonal-balance\/the-fda-reconsiders-its-warnings-on-hormone-therapy-in-menopause-the-beginning-of-a-new-era-for-womens-health\/","title":{"rendered":"The FDA Reconsiders Its Warnings on Hormone Therapy in Menopause: The Beginning of a New Era for Women\u2019s Health?"},"content":{"rendered":"
\n

The combination of bioidentical estradiol and micronized progesterone has shown, according to scientific literature, no association with thrombotic events or an increased risk of breast cancer.<\/strong><\/h1>\n

The warnings about hormone replacement therapy (HRT) date back to 2002, when the Women\u2019s Health Initiative (WHI) study linked the combined therapy CEE + MPA (Conjugated Equine Estrogens + Medroxyprogesterone Acetate) to an increased risk of breast cancer and cardiovascular events.<\/em><\/p>\n

Dr. Alfonso Gal\u00e1n \u2013 Neolife Medical Team<\/em><\/p>\n

\n

Women suffering from debilitating symptoms were kept away from an effective treatment due to unfounded fears, losing quality of life as well as bone and vascular protection.<\/strong><\/p>\n

In July 2025, the U.S. Food and Drug Administration (FDA) convened a panel of experts to reevaluate the evidence surrounding Hormone Replacement Therapy (HRT)<\/strong> in menopausal women. This marks a turning point in the institutional narrative that, for decades, has been dominated by fear, black box warnings, and a distorted perception of risk. <\/b><\/span><\/p>\n

At Neolife<\/b>, we welcome this step as an act of scientific and medical justice<\/strong> \u2014 <\/b>but also as a reminder of the great harm that misinformation about HRT<\/b> has caused. In this article, we analyze in depth the panel\u2019s conclusions, the key studies discussed, and, above all, the fact that the formulations we use at Neolife (bioidentical estradiol<\/b> and micronized progesterone<\/b>) have shown no increase in cardiovascular or cancer risk. <\/span><\/p>\n

\"TRHB<\/p>\n

What Was Said at the FDA Panel?<\/p>\n

    \n
  1. Removal of the most severe warnings (black box warnings) for certain forms of HRT.<\/li>\n
  2. Recognition of previously minimized benefits: cardiovascular protection, improved bone health, reduction of hot flashes, and enhanced mood\u2014especially in women under 60 or within the first 10 years after menopause.<\/li>\n
  3. Lack of differentiation between formulations: one major criticism was the failure to distinguish between treatments using conjugated equine estrogens (CEE) and medroxyprogesterone (MPA), versus bioidentical options.<\/li>\n<\/ol>\n

    The Legacy of the WHI and Its Consequences<\/strong><\/p>\n

    The warnings about HRT<\/b> trace back to 2002, when the Women\u2019s Health Initiative<\/strong> linked CEE + MPA<\/b> to an increased risk of breast cancer and cardiovascular events. However, in the years since, it has become clear that: <\/span><\/p>\n

      \n
    • The observed risk does not apply to all formulations or all women.<\/li>\n
    • The late age of treatment initiation (average age in WHI: 63 years) distorted the outcomes.<\/li>\n
    • The study did not use bioidentical estrogens or micronized progesterone.<\/li>\n<\/ul>\n

      As a result, millions of women gave up a beneficial therapy based on fears that we now consider unfounded for many patients.<\/span><\/p>\n

      Current Evidence: What Does Science Say About Bioidentical HRT?<\/strong><\/p>\n

      Studies such as E3N (France)<\/strong> <\/b>have demonstrated that<\/span> <\/b>oral bioidentical estradiol combined with micronized progesterone<\/strong> does not increase breast cancer risk (RR: 0.9).<\/span><\/p>\n

      A meta-analysis (Scarabin, 2018) confirms that the safest combination is transdermal estradiol plus micronized progesterone<\/strong>, <\/b>with no significant increase in thromboembolic risk.<\/span><\/p>\n

      Differences between formulations<\/strong><\/p>\n

      \"Menopause<\/p>\n

      The Neolife Approach: Evidence, Personalization, and Safety<\/strong><\/p>\n

      At Neolife<\/b>, we use HRT<\/b> in a personalized and evidence-based manner, with:<\/span><\/p>\n

        \n
      • Bioidentical estradiol<\/li>\n
      • Micronized progesterone<\/li>\n
      • Regular clinical and laboratory monitoring<\/li>\n<\/ul>\n

        This combination has consistently shown no association with thrombotic events or increased breast cancer risk in the short- to medium-term scientific literature.<\/span><\/p>\n

        What Happens Next?<\/strong><\/p>\n

        If the FDA is now willing to reconsider its most severe warnings based on current evidence, the next logical step would be to retract and acknowledge<\/strong> the harm caused over the past two decades.
        Women with debilitating symptoms were denied an effective treatment due to misplaced fears, losing not only quality of life<\/b> but also bone and vascular protection<\/b>. <\/span><\/p>\n

        Medicine must have the courage to correct its course. Today, we know that well-prescribed, bioidentical, and personalized HRT<\/b> is a powerful, effective, and safe tool for many women. <\/span><\/p>\n

        Conclusion<\/strong><\/p>\n

        The FDA<\/b> panel marks a shift in direction, but there is still a long road ahead \u2014 many physicians and patients remain to be educated. At Neolife,<\/b> we have long applied an evidence-based approach, free from dogma and with safety as our top priority. It is time to rewrite the narrative of HRT<\/b> \u2014 with science, prudence, and respect for women\u2019s health. <\/span><\/p>\n

        \n

        BIBLIOGRAPHY<\/p>\n

        (1) Scarabin, P. Y.<\/strong> (2018). Progestogens and venous thromboembolism in menopausal women: an updated oral versus transdermal estrogen meta-analysis.<\/em> Climacteric<\/strong>, 21(4), 341\u2013345.<\/p>\n

        (2) Fournier, A. et al.<\/strong> (2008). Use of different postmenopausal hormone therapies and risk of histology- and hormone receptor-defined invasive breast cancer.<\/em> Journal of Clinical Oncology<\/strong>, 26(8), 1260\u20131268.
        \n(E3N cohort, Francia)<\/em><\/p>\n

        (3) Manson, J. E. et al.<\/strong> (2013). Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials.<\/em> JAMA<\/strong>, 310(13), 1353\u20131368.<\/p>\n

        (4) The NAMS 2022 Hormone Therapy Position Statement Advisory Panel<\/strong>. (2022). The 2022 Hormone Therapy Position Statement of The North American Menopause Society.<\/em> Menopause<\/strong>, 29(7), 767\u2013794. <\/p>\n

        (5) FDA Expert Panel on Menopause and Hormone Replacement Therapy<\/strong> (2025). U.S. Food & Drug Administration Public Meeting Archive: July 17, 2025.<\/em><\/p>\n

        \n","protected":false},"excerpt":{"rendered":"

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The warnings about hormone replacement therapy (HRT) date back to 2002, when the Women\u2019s Health Initiative (WHI) study linked the combined therapy CEE + MPA (Conjugated Equine Estrogens + […]<\/p>\n","protected":false},"author":7,"featured_media":29541,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[333],"tags":[5402,4991,5399,4124,5401,5400,4109,5403,4994,4110,4123,1178,5404,5405],"class_list":["post-29564","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hormonal-balance","tag-bioidentical-en","tag-cancer-de-mama-en","tag-cardiovascular-risk-en","tag-estradiol-en","tag-heart-attack-en","tag-ictus-en","tag-menopausia-en","tag-micronized","tag-osteoporosis-en","tag-progesterona-en","tag-terapia-hormonal-en","tag-trh","tag-venous-thrombosis","tag-whi-study"],"acf":[],"yoast_head":"\nThe FDA Reconsiders Its Warnings on Hormone Therapy in Menopause: The Beginning of a New Era for Women\u2019s Health? 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