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The FDA Removes Black Box Warnings from Hormone Therapy

Writer: Sara Stryker
Sara Stryker
Nov 11, 2025
4 min read

Updated: Sep 13

At Stryker Optimal Health and Wellness in Spokane Valley, we specialize in personalized hormone therapy that helps women restore balance, energy, and confidence.


If you’ve been told “your labs are normal” but still don’t feel like yourself, it’s time to get answers. Schedule your hormone consultation today and learn how functional, evidence-based care can change your life.


Serving Spokane Valley, Liberty Lake, and the greater Spokane area.


The FDA has officially removed several black box warnings from hormone replacement therapy (HRT) medications. This is a significant development.


For over 20 years, those warnings scared women away from hormone therapy. Many providers were too nervous to prescribe it. The result? Countless women suffered with symptoms that could have been treated safely. Now, that’s changing.


Understanding the FDA’s Decision


The Science Behind the FDA’s Decision


After reviewing decades of research, the FDA found that many of the old warnings were outdated and misleading. Here’s what’s new:


  • The warnings about heart disease, breast cancer, and dementia are being removed.

  • The only boxed warning that will remain is for endometrial cancer when estrogen is taken without progesterone (this has always been known and managed safely).

  • The FDA now encourages women to start HRT within 10 years of menopause or before age 60, when the benefits are most substantial.


This means that science has caught up with what many experts have said for years: that hormones, when used properly, can protect your long-term health.


The Benefits of Starting HRT Early


Starting hormone therapy early offers significant health benefits. Studies show women who begin HRT at the right time have:


  • 50% lower risk of heart attack

  • 64% lower risk of memory loss and cognitive decline

  • 35% lower risk of Alzheimer’s

  • Stronger bones and fewer fractures

  • Lower overall risk of death


In short, hormone therapy isn’t something to fear. It’s something that can help you feel better, live longer, and stay healthier.


What About Compounded Hormones?


The FDA changes only apply to commercial, FDA-approved hormone medications, not compounded bioidentical hormones. But this update still matters. It shows the medical community now recognizes what many women already know: balanced hormones are powerful and safe when prescribed correctly.


Two-column graphic comparing the Complete Health & Hormone Panel and the Elite Functional Health & Hormone Panel offered by Stryker Optimal Health and Wellness. The left column lists the Complete Panel for $225, which includes general health, thyroid, nutritional, and hormone markers totaling 47–48 biomarkers. The right column lists the Elite Panel for $435, which includes a more extensive set of metabolic, thyroid, functional, and hormone markers totaling 58–59 biomarkers. Both panels show detailed lab components such as CBC, cortisol, insulin, testosterone, and vitamin levels. A banner at the bottom notes: “Book your lab panel before Dec 31 to lock in current pricing. Prices increase Jan 1.
Spots are filling fast! Book your hormone lab appointment now to lock in 2025 pricing and secure your spot before schedules fill. Don’t wait, menstruating women should plan ahead to align testing with their cycle for the most accurate results.

What This Means for You at Stryker Optimal Health and Wellness


At Stryker Optimal Health and Wellness, we’ve always focused on helping women feel their best through balanced hormones, personalized care, and functional medicine.


This new FDA update is a significant step forward for women’s health. It gives reassurance to every woman who has wondered if hormone therapy is right for her.


If you’ve been struggling with hot flashes, brain fog, fatigue, low mood, or weight gain, it might be time to talk about hormone therapy. We’ll review your symptoms, lab results, and goals to find what works best for your body, safely and effectively.


Functional Care for Women in Spokane Valley


Hormone therapy isn’t something to fear anymore. It’s something that can help you get your life back on track.


Why Choose Stryker Optimal Health and Wellness?


Choosing the right place for your hormone therapy is crucial. At Stryker Optimal Health and Wellness, we pride ourselves on our personalized approach. We understand that every woman’s body is unique. That’s why we tailor our treatments to meet your individual needs.


Our Comprehensive Services


We offer a range of services designed to support your hormone health. From thorough lab testing to personalized treatment plans, we ensure you receive the best care possible. Our goal is to empower you to take control of your health.


The Importance of Education


We believe in educating our patients. Understanding your body and the changes it undergoes is vital. We provide resources and information to help you make informed decisions about your health.


Community Support


Being part of a supportive community can make a difference. At Stryker Optimal Health and Wellness, you’ll find a welcoming environment. Connect with others who share similar experiences and challenges.


The Future of Hormone Therapy


As we look ahead, the future of hormone therapy appears promising. With new research and changing regulations, more women will have access to safe and effective treatments. This is a vital step in improving women's health overall.


Embracing Change


Change can be daunting, especially when it comes to health. However, embracing these changes can lead to better health outcomes. Women are encouraged to explore their options and seek guidance from professionals.


The Role of Healthcare Providers


Healthcare providers play a crucial role in this transition. They must stay informed about the latest research and guidelines. This ensures they can provide the best care possible to their patients.


The Importance of Personalization


Every woman’s experience with hormone therapy will be different. Personalization is key. Tailoring treatments to individual needs can lead to better results and improved quality of life.


Staying Informed


Staying informed about hormone therapy is essential. Women should seek out reliable information and consult with healthcare providers. This empowers them to make the best decisions for their health.


Schedule a consultation at Stryker Optimal Health and Wellness to see if HRT is right for you.


Additional Readings:


  1. The American College of Obstetricians and Gynecologists (ACOG). “Hormone Therapy for Menopause.” Available at: https://www.acog.org/womens-health/faqs/hormone-therapy-for-menopause

  2. The North American Menopause Society (NAMS). “Menopause Topics: Hormone Therapy.” Available at: https://menopause.org/patient-education/menopause-topics/hormone-therapy

  3. The Clinical Advisor. “FDA Requests Removal of Boxed Warnings for Menopausal Hormone Therapy.” Available at: https://www.clinicaladvisor.com/news/fda-requests-removal-of-boxed-warnings-for-menopausal-hormone-therapy/

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