Forum Health Applauds FDA Decision to Remove “Black Box” Warnings from Menopause Hormone Therapy

Move marks a historic step toward restoring evidence-based access to life-changing care for millions of women.

LISLE, Ill., Nov. 24, 2025 /PRNewswire/ — The nationwide integrative and functional medicine network Forum Health today praised the U.S. Food and Drug Administration’s decision to initiate the removal of broad “black box” warnings from menopausal hormone replacement therapy (HRT) products, calling it a long-overdue correction that will help more women access safe, effective relief from debilitating menopause symptoms.

The Department of Health and Human Services (HHS) recently announced that, after a comprehensive review of decades of data, the FDA will ask manufacturers to remove boxed warnings that have contributed to fear and underuse of HRT for hot flashes, night sweats, sleep disruption, genitourinary symptoms, and other menopause-related concerns. Updated labels will instead emphasize individualized risk–benefit discussions, including strong evidence that, for many women who initiate therapy within 10 years of menopause onset, the benefits can outweigh the risks.

“This is an important day for women’s health,” said Shilpa P. Saxena, MD, Chief Medical Officer at Forum Health. “For more than two decades, broad warning language has potentially deterred countless women from considering therapies that could have safely relieved their symptoms and protected their long-term health. This decision better aligns regulation with the science and opens the door for more informed, nuanced conversations between women and their providers.”

Forum Health: On the vanguard of women’s hormone care

For years, Forum Health and its Hormones By Design clinics have been on the vanguard of women’s hormone health—prioritizing personalized, bioidentical hormone therapy, advanced diagnostics, and ongoing monitoring over “one-size-fits-all” prescribing.

Board-certified OB/GYN Melissa Miskell, DO, a nationally recognized hormone health expert and Forum Health provider in Texas, has spent more than two decades helping thousands of women navigate perimenopause and menopause with individualized hormone therapy protocols.

“The removal of these black box warnings is not about making hormone therapy ‘risk-free’—it’s about making it honestly and accurately represented,” said Dr. Miskell. “When we combine up-to-date evidence with careful screening, low-cost comprehensive labs, and close follow-up, we see women reclaim their energy, sleep, mood, libido, and overall quality of life in profound ways.”

Forum Health’s approach to menopause care includes:

• Root-cause evaluation: Extensive symptom review and advanced lab testing to understand each woman’s unique hormonal landscape.
• Personalized treatment plans: Bioidentical hormones delivered via injections, pellets, and topicals, alongside nutrition, sleep, stress, and metabolic support.
• High-touch, virtual and in-clinic care: Monthly or periodic visits that allow rapid dose adjustments and real-time symptom tracking, rather than static annual refills.

A call for informed, individualized decisions

The FDA’s action does not remove important safety information; instead, it replaces broad, fear-based language with more precise guidance around timing, dosing, and individual risk factors such as age, cardiovascular history, and history of estrogen-sensitive cancers.

Forum Health encourages women who previously avoided hormone therapy due to the black box warning to re-engage with a qualified provider to reassess their options in light of the updated labels and current science.

Women interested in learning whether hormone replacement therapy may be appropriate for them can schedule consultations through Forum Health’s nationwide network of clinics and virtual providers.

About Forum Health, LLC

Forum Health, LLC is a nationwide network of personalized healthcare providers steeped in the powerful principles of functional and integrative medicine. Forum Health providers take a root-cause approach to care, exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Patients have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships.

Forum Health, LLC’s parent company, Forum Health Enterprises, Inc., is a full-service Integrative Health/Functional Medicine Ecosystem, supplying a full suite of services including Inwell Biosciences, a nutraceutical provider, and Power2Practice, a full-service technology-enabled EMR practice management solution. For more information, visit www.forumhealth.com.

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SOURCE Forum Health, LLC