- Currently, menopause symptoms are treated through lifestyle changes, alternative therapies, medications, and hormone replacement therapy (HRT).
- In January 2003, the U.S. The Food & Drug Administration (FDA) issued “black box” warnings for HRT about the potential increased risk for certain health conditions.
- Earlier this week, the FDA announced it would be removing these warnings from HRT products due to more recent research disproving these initial risks.
According to the European Institute of Women’s Health, about 25 million women around the world enter menopause each year
Menopause is a natural occurrence for cisgender women ages 45 to 55, when their menstrual cycle ends, ending their reproductive years
Past research shows that about 85% of women
experience a variety of symptoms during menopause, such as hot flashes, vaginal dryness, sleeping issues, depression, mood swings, weight gain, and difficulty concentrating
Currently, menopause symptoms are treated through lifestyle changes, alternative therapies like yoga and meditation, certain medications, and hormone replacement therapy (HRT), also called menopausal hormone therapy (MHT) or hormone therapy (HT)
In January 2003, the U.S. The Food & Drug Administration (FDA) issued “black box” warnings for HRT medications based on the results of the Women’s Health Initiative (WHI) study, with warnings about the potential increased risk for health conditions like breast cancer, dementia, and cardiovascular disease when taking HRT
Earlier this week, the FDA announced
it would be removing these warnings from HRT products due to more recent research disproving these specific risks
Medical News Today spoke with five women’s health experts to find out more about what HRT is, what are the “black box” warnings being removed, and what does this mean for women’s access to HRT for menopause symptoms
What is hormone replacement therapy?
According to Susan Marie Pacana, MD, a minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, and a Menopause Society Certified Practitioner, HRT is prescription estrogen, progesterone, and sometimes testosterone therapy prescribed for peri and/or postmenopausal women to replace the hormones that decline with menopause
“The typical reasons for taking HRT include relief of symptoms such as night sweats, hot flashes, vaginal dryness, decreased libido, and mood changes,” Pacana added
“During the menopause transition, the ovaries stop producing estrogen and progesterone which are the hormones responsible for reproduction, periods, and other important bodily functions,” Sherry Ross, MD, a board certified OB/GYN and Women’s Health Expert at Providence Saint John’s Health Center in Santa Monica, CA, explained to MNT
How HRT can help menopause symptoms
“Losing these important female hormones affect almost every organ in our body and are profoundly affected by their absence. A tsunami of bothersome symptoms occur that can be reversed and avoided if you are prescribed hormone therapy. Taking hormone therapy, including estrogen and progesterone can minimize the majority of disruptive symptoms experienced by women.”— Sherry Ross, MD
“Decades ago, beginning around 1945, a product called Premarin, derived from the urine of pregnant horses, was commonly prescribed along with synthetic progesterone,” Prudence Hall, MD, an OB/GYN in private practice in Santa Monica, CA, and author of Radiant Again & Forever: Overcome Menopause & Restore Your Radiance,toldMNT
“Today, we have far better, more natural options. The form of HRT I use is bioidentical, meaning these hormones are molecularly identical to those naturally produced by a woman’s body,” she said
Why are the ‘black box’ warnings being removed from HRT?
On November 10, 2025, the FDA announced it is working with healthcare companies to update the “black box warnings” currently on HRT products to remove risks for cardiovascular disease, breast cancer, and probable dementia, and add the FDA’s recommendation of starting HRT within 10 years before the start of menopause or before age 60
“The ‘black box’ warnings note an increased risk of heart disease, dementia, and breast cancer with HT use,” Jan L Shifren, MD, director of the Midlife Women’s Health Center at Massachusetts General Hospital and Vincent Trustees Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, told MNT
“These warnings were added after completion of the Women’s Health Initiative (WHI) trial of hormone therapy demonstrating these risks in women randomized to receive HT or a placebo. The average age of women in the WHI trial was 63, and later analyses of this study showed that for women in WHI under age 60 or within 10 years of menopause, the balance of risks and benefits was much more favorable.” — Jan L Shifren, MD
“Risks still will be included in the package insert for HT, but with more discussion of the impact of age,” Shifren added. “This seems to be the principal reason the FDA decided to remove the ‘black box’ warnings.”
“The key to starting hormone replacement therapy within 10 years of the onset of menopause is because at that point, and this is women in their 50s, they still have estrogen receptors,” said G. Thomas Ruiz, MD, a board certified OB/GYN and Lead OB/GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA. “If you have estrogen receptors, there’s going to be a benefit to taking hormones. And estrogen receptors are everywhere in a woman’s body — connective tissue, bone, [m]uscle, and brain.”
What do new studies say about the safety of HRT?
The FDA’s decision to remove certain ‘black box’ warnings from HRT products stems from the findings of more recent research showing the potential benefit of these medications
For example, regarding brain health, a study published in January 2023 found a link between HRT use and improved cognition and brain volume
in people at a genetically higher risk for a type of dementia called Alzheimer’s disease
In regard to heart health, a review article published in May 2022 noted that HRT significantly reduces cardiovascular disease and all-cause mortality when started in women younger than 60 years of age and/or at or near menopause
A study published in June 2025 discovered that women taking unopposed estrogen hormone therapy (E-HT) before age 55 had a 14% lower risk
for breast cancer compared to women not taking HRT
Additionally, research presented during the 2025 Annual Meeting of The Menopause Society reported that perimenopausal women taking estrogen within 10 years before menopause had no significantly higher associated rates of stroke, breast cancer, or heart attack
What does this mean for access to HRT for menopause?
All of our experts believe removing these “black box” warnings from HRT will help make it more accessible to women who need it
“By the FDA removing the misleading ‘black box’ warning for hormone therapy to treat menopausal women, this supports all the benefits that hormone therapy affords women for healthy aging and longevity,” Ross commented
“Reducing stigma around treatments like HRT can have a lasting positive impact on patients’ willingness to seek care,” Pacana added. “A doctor’s main goal is to provide effective and safe treatments, and ensuring HRT products are held to high standards of efficacy and safety is essential for patient health.”
“We hope that removing the black box will allow women and their health care providers to engage in greater shared decision-making about HT use, with less fear.”— Jan L Shifren, MD
“Hormones act as the body’s internal software, sending vital instructions that keep every system functioning smoothly,” Hall explained. “When this essential biological software declines, the body loses its ability to perform at its best. Maintaining balanced, optimized hormones is fundamental to sustaining health, energy, and overall well-being throughout life.”
Ruiz said that they continue to see some primary care providers (PCPs) “still living by the credo of the old study that says you should only offer hormone replacement therapy to women who are severely symptomatic, meaning with their vasomotor symptoms, and leave them on it for a finite period of time before stopping their hormone replacement therapy.”
“If (you) have a primary care provider who is still reluctant to follow the new data, [t]alk to (your) OB/GYN or a family medicine doctor who does lots of women’s healthcare,” Ruiz suggested
