Reviewed by Dr. Chad Gilliam PA
Reading time: four minutes
In November 2025, the FDA announced an important update: the removal of the long-standing black box warning from hormone replacement therapy (HRT) medications. This change is one of the biggest advancements in women’s hormone health in decades and reflects updated research showing that hormone therapy is safe and effective when prescribed appropriately.
Why the Black Box Warning Was Added
The black box warning originated in the early 2000s after early Women’s Health Initiative (WHI) data suggested increased risks of breast cancer, stroke, heart attack, and dementia among hormone therapy users.
However, later analysis revealed key issues:
- Many participants were older than the typical age of starting hormone therapy.
- Hormone types and doses differed from today’s commonly used options.
- Risks were overstated or misunderstood, especially for women who begin therapy near the onset of menopause.
Despite this updated understanding, the warning remained in place for more than 20 years.
Why the FDA Removed the Warning
After reviewing a wide body of evidence and expert recommendations, the FDA acknowledged that the previous warning no longer reflects modern understanding of hormone therapy.
Current research shows:
- Hormone therapy is safe for many women when timed and dosed appropriately.
- Benefits often outweigh risks for women near the menopausal transition.
- Modern, individualized approaches to hormone therapy offer improved safety and stability.
This update allows women and clinicians to discuss treatment options without outdated fear overshadowing the benefits.
Why This Change Matters for Women’s Health
Removing the black box warning gives women more access to therapies that can significantly improve sleep, energy, mood, weight regulation, cognitive clarity, and overall quality of life. Instead of avoiding treatment, women can now work with experienced hormone specialists to determine whether therapy is appropriate for their needs.
Madison Wellness and Aesthetic Center has long supported individualized, evidence-based hormone care. With more than 15 years of clinical experience and over 16,000 pellet procedures performed, their team has seen firsthand how restoring balanced hormone levels can support better long-term health and daily comfort.
What Is BHRT (Bioidentical Hormone Replacement Therapy)?
Bioidentical Hormone Replacement Therapy uses hormones that are structurally identical to those naturally produced by the body. Because they match the body’s own hormone structure, they are processed in a familiar and predictable way.
Madison Wellness and Aesthetic Center we offer BHRT as a personalized treatment option designed to support:
- Stable energy
- Improved sleep
- More balanced mood
- Cognitive clarity
- Weight regulation
- Libido and sexual wellness
- Temperature control and comfort
Hormone therapy for women at Madison Wellness and Aesthetic Center is:
- Highly individualized, based on lab testing and symptoms.
- Versatile, with options such as creams, gels, and pellet therapy.
- Focused on restoring balance, rather than masking symptoms.
With more than 15 years of experience and over 16,000 pellet procedures performed, our team is a trusted provider for women seeking safe, effective hormone support.
EvexiPEL®: A Modern Approach to BHRT
EvexiPEL® pellet therapy is one of the most advanced BHRT options available. Pellets are placed just beneath the skin and designed to release hormones gradually over several months, avoiding the daily fluctuations seen with oral or topical therapies.
EvexiPEL® pellets are:
- Plant-derived and bioidentical, matching the structure of natural hormones.
- Long-acting, providing consistent dosing for 3–6 months.
- Customized based on detailed lab results and personal symptoms
Why We Work With EvexiPEL®
We choose the EvexiPEL® brand because it delivers consistent, steady hormone support and aligns with our individualized approach to care. EvexiPEL® offers:
- Steady hormone delivery
- Predictable symptom relief
- Reduced fluctuations in mood and energy
- Personalized dosing based on your hormone profile
- Convenient, long-lasting treatment
We trust EvexiPEL® because it helps create a stable hormone environment, allowing our patients to experience clearer thinking, improved comfort, and better daily well-being.
What This Update Means for Your Hormone Health
The FDA’s decision supports what modern research and experienced providers already know: individualized hormone therapy can play an important role in women’s long-term well-being.
To book an appointment at our wellness center in Madison, AL, call (256) 722-0555 or visit us at 844 Slaughter Rd. Suite A, Madison, AL.
FAQS
The FDA determined that the previous warning no longer reflects current research. Updated evidence shows that hormone therapy can be safely used when individualized and monitored by a trained provider.
The update supports more open conversations about hormone therapy, but treatment is still based on individual evaluation, lab work, and your personal health history.
The FDA’s updated guidance removes outdated risk messaging and supports a more individualized approach to hormone therapy. The agency now emphasizes appropriate timing, personalized evaluation, and shared decision-making between patient and provider.
Look for a provider who offers comprehensive lab testing, individualized dosing, ongoing monitoring, and experience with modern hormone therapy methods. Providers with advanced training and an established track record can offer more precise, consistent care.
Who offers hormone replacement therapy in Madison, AL?
Madison Wellness and Aesthetic Center provides individualized BHRT and EvexiPEL® pellet therapy with more than 15 years of experience and over 16,000 pellet procedures performed. To book a consultation, call (256) 722-0555.
