‘Black box’ safety warning to be removed from hormone therapy for menopause

At Miami Primary, we welcome the FDA and HHS’s recent decision to remove the outdated “black box” warning from many menopausal hormone therapies. This is an important and long-awaited step toward restoring confidence in a treatment that has helped countless women regain their health, balance, and quality of life.

For more than 20 years, the black box warning—added in 2003 after early results from the Women’s Health Initiative (WHI)—has caused unnecessary fear and confusion around hormone therapy. Those early studies, which focused mostly on women well past menopause, suggested higher risks of heart disease, stroke, breast cancer, and dementia. Unfortunately, those findings were misinterpreted and generalized to all women, leading to a dramatic decline in the use of hormone therapy and leaving millions to suffer needlessly through menopause symptoms.

Today, new research tells a very different story. Studies now show that when hormone therapy is started around the time of menopause (especially in women under 60 or within 10 years of their last period), it can be both safe and highly beneficial—helping with hot flashes, mood changes, sleep disturbances, and even long-term health outcomes like bone, heart, and brain health.

The FDA’s updated guidance allows for a more personalized, science-based approach. It removes the overly broad “one-size-fits-all” warning and replaces it with more balanced information that considers age, timing, type of therapy, and individual risk factors. This change also eliminates outdated advice to use “the lowest dose for the shortest time,” opening the door for women to stay on therapy longer when it’s medically appropriate.

As FDA Commissioner Dr. Marty Makary stated, “After 23 years of dogma, we are going to stop the fear machine steering women away from this life-changing treatment.” At Miami Primary, we couldn’t agree more.

Our team believes that women deserve options, and those options should be based on current medical evidence—not fear from decades-old data. We support a thoughtful, individualized approach where each woman can discuss her unique goals, health history, and symptoms with her provider to determine whether hormone therapy is right for her.

The FDA’s decision comes alongside a growing national effort to improve menopause care, awareness, and education. Many states are now taking action to ensure women have better access to treatment and that clinicians receive updated training in menopause management.

At Miami Primary, we are proud to be part of this movement. We are committed to helping women understand their bodies, their hormones, and their choices—so they can thrive through menopause and beyond.

If you’re experiencing menopause symptoms or have questions about hormone therapy, our team is here to provide expert, compassionate guidance based on the latest science and FDA-approved standards.

Miami Primary — Empowering women through every stage of life. * References: https://www.cnn.com/2025/11/10/health/hormone-therapy-menopause-fda-warning-wellness?cid=android_app https://www.hhs.gov/press-room/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy.html