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FDA Removes Black Box Warning on Menopause Hormone Therapy: What It Means for Your Wellness

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In November 2025, the United States Food and Drug Administration removed the black box warning from hormone therapy products for menopause.

The move overturned a 2003 FDA decision to place the warning on hormone therapy products for menopause because of potential health risks. In removing the warning, the FDA said those risks aren’t the same for all users of hormone therapy. It added that women may have been “underutilizing” the treatment because of the black box warning.

Hormone therapy can help reduce symptoms of menopause. The benefits are greater, and the risks are lower, for younger women who begin the treatment early in menopause.

Learn more about the impact of the FDA black box warning removal on menopausal hormone therapy. Discover how the FDA changes affect hormone therapy for women’s health.

What Is Hormone Therapy for Menopause?

After menopause, your body makes significantly less estrogen and progesterone. Menopausal hormone therapy (MHT), also known as hormone replacement therapy, boosts the body’s levels of these hormones. Doctors may prescribe it to relieve symptoms of menopause like hot flashes and night sweats.

Hormone therapy can come in many forms — including pills, patches, and vaginal rings. There are two main types of hormone therapy for menopause:

  • Estrogen therapy — You receive estrogen only.
  • Combination therapy — Involves both estrogen and a progestogen. Women who haven’t had a hysterectomy will receive combination therapy to reduce their risk of uterine cancer.

Hormone therapy can also be systemic or local:

  • Local therapy — Delivers hormones into vaginal tissue to treat symptoms like vaginal dryness. It may take the form of a vaginal ring or cream.
  • Systemic therapy — Delivers hormones into your bloodstream, such as through pills, skin patches, or gels. It can help treat more systemic side effects of menopause, such as night sweats and hot flashes.

What Are the Benefits of Hormone Therapy?

There are many benefits of menopausal hormone therapy. It can lessen several common symptoms and complications of menopause, including:

While research is ongoing, some studies indicate that hormone therapy may help reduce the risk of certain health conditions, including:

  • Cardiovascular disease — Hormone therapy may reduce your risk of cardiovascular disease if you begin to take it before age 60 or within 10 years of starting menopause.
  • Colon cancer — Combination therapy may reduce the risk of colon cancer.
  • Dementia — Some research has linked estrogen-only hormone therapy with a lower risk of dementia and Alzheimer’s disease.
  • Osteoporosis — Hormone therapy can reduce bone loss, which can lower the risk of postmenopausal osteoporosis.
  • Type 2 diabetes — Hormone therapy may lower your risk of type 2 diabetes.

However, hormone therapy isn’t recommended solely to prevent diseases.

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Are There Risks with Hormone Therapy?

Hormone therapy does carry risks, including:

  • Blood clots — Hormone therapy may bring a higher risk of blood clots, especially when taken orally.
  • Certain cancers — Experts have linked estrogen-only therapy with a higher risk of uterine (endometrial) cancer, but progestin can help decrease that risk.
  • Gallbladder disease — There’s an increased risk of gallbladder disease with hormone therapy, especially when taken orally.
  • Heart disease and dementia — Hormone therapy may increase the risk of heart disease and dementia when it’s initiated after age 60 or more than 10 years after the onset of menopause.
  • Stroke — Estrogen-only therapy and combination therapy are both associated with an increased risk of stroke in older women. The risk is lower when using an estrogen patch or vaginal estrogen.

Hormone therapy also may cause side effects, including:

  • Bloating.
  • Breast pain.
  • Headaches.
  • Vaginal spotting or bleeding.

Why Did the FDA Place a Black Box Warning on Hormone Therapy?

The FDA placed a black box warning on hormone therapy after a 2002 study on potential health risks of the treatment. The study, from the Women’s Health Initiative (WHI), linked hormone therapy to a higher risk of:

  • Blood clots
  • Breast cancer
  • Dementia
  • Heart disease
  • Stroke

The use of hormone therapy dropped significantly after the FDA put the black box warning in place.

Why Did the FDA Remove the Black Box Warning on Hormone Therapy?

According to the FDA, continued research on hormone therapy has provided more context about the potential risks and benefits.

The 2002 WHI study featured women with an average age of 63. However, the study aimed to look at hormone therapy for disease prevention in older women, rather than young, healthy symptomatic menopausal women.

“We have learned that timing matters, and that the risks of hormone therapy cannot be applied to all formulations and routes,” says Sarah Richina, MD, medical director of the UPMC Magee-Womens Midlife Health Center. “The benefits often outweigh risks of hormone therapy in healthy symptomatic women who are within 10 years of their final menstrual period or before the age of 60.”

The type of hormone therapy taken — estrogen-only or combination, and systemic vs. local therapy — also carries different risks and benefits.

The FDA is seeking to revise labeling of hormone therapy to more appropriately reflect risks of contemporary data and regimens. It isn’t removing language about the risk of endometrial cancer on estrogen-only products.

Is Hormone Therapy Safe After the FDA Removed the Black Box Warning?

The risks and benefits of hormone therapy vary depending on the person.

Hormone therapy can relieve the symptoms of menopause, improving your quality of life. It may also help lower the risk of certain chronic health conditions. It is especially beneficial if you begin taking it before age 60 or within 10 years of starting menopause.

But hormone therapy also carries risks for people, particularly people with a history of:

  • Blood clots
  • Certain cancers
  • Heart disease
  • Stroke

You shouldn’t use menopausal hormone therapy if you have:

  • Hormone-sensitive cancer.
  • Liver disease.
  • Unexplained abnormal vaginal bleeding.

You should stop taking hormone therapy if you’re pregnant or think you may be pregnant. You also shouldn’t use hormone therapy solely for the prevention of disease.

Is Hormone Therapy for Menopause Right for Me?

Hormone therapy is an individual decision that you should base on informed decision-making.

The Menopause Society says risks are lower for younger and healthier women who begin the treatment closer to the onset of menopause. Women who are older or who began menopause longer ago face greater risks.

Forms of hormone therapy applied to the skin may carry lower risks of complications than pills and injections.

If you’re in perimenopause or menopause and want to learn more about hormone therapy, talk to your healthcare provider.

What Lifestyle Habits Can Help with Menopause Symptoms?

Healthy habits during menopause can benefit your midlife health and wellness. Lifestyle tips for managing menopause symptoms along with hormone therapy include:

  • Eating a healthy diet.
  • Exercising regularly.
  • Getting enough sleep.
  • Reducing stress.
  • Taking recommended vitamins and supplements.
  • Visiting your doctor regularly.

At UPMC Magee-Womens, we provide expert care for women at every stage of life, including menopause.

The Menopause Society has certified many of our providers as Menopause Society Certified Practitioners (MSCP). They can discuss your individual risks and benefits and provide recommendations on safe hormone therapy options for you.

If hormone therapy isn’t right for you, they can recommend other treatments for menopause symptoms.

For more information on the midlife health services we provide, visit our website.

American College of Obstetricians and Gynecologists, Hormone Therapy for Menopause. Accessed December 2025. Hormone Therapy for Menopause | ACOG Link

Leslie Cho, MD, Andrew M. Kaunitz, MD, Stephanie S. Faubion, MD, MBA, et al, Circulation, Rethinking Menopausal Hormone Therapy: For Whom, What, When, and How Long? Accessed December 2025. Rethinking Menopausal Hormone Therapy: For Whom, What, When, and How Long? | Circulation Link

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North American Menopause Society, The Menopause Society Comments on the FDA Announcement on Hormone Therapy. Accessed December 2025. The Menopause Society Comments on the FDA Announcement on Hormone Therapy | The Menopause Society Link

North American Menopause Society, The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Accessed December 2025. nams-2022-hormone-therapy-position-statement.pdf Link

Jesse Pines, Forbes Health, FDA Lifts Menopause Drug Warnings. Here’s What You Need To Know, From A Doctor. Accessed December 2025. FDA Lifts Menopause Drug Warnings. Here’s What You Need To Know, From A Doctor Link

Roni Caryn Rabin, The New York Times, F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause. Accessed December 2025. F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause - The New York Times Link

U.S. Department of Health and Human Services, FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products. Accessed December 2025. FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products | HHS.gov Link

U.S. Preventive Services Task Force, Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons: US Preventive Services Task Force Recommendation Statement. Accessed December 2025. Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons: US Preventive Services Task Force Recommendation Statement | Gynecology | JAMA | JAMA Network Link

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About UPMC Magee-Womens

Built upon our flagship, UPMC Magee-Womens Hospital in Pittsburgh, and its century-plus history of providing high-quality medical care for people at all stages of life, UPMC Magee-Womens is nationally renowned for its outstanding care for women and their families.

Our Magee-Womens network – from women’s imaging centers and specialty care to outpatient and hospital-based services – provides care throughout Pennsylvania, so the help you need is always close to home. More than 25,000 babies are born at our network hospitals each year, with 10,000 of those babies born at UPMC Magee in Pittsburgh, home to one of the largest NICUs in the country. The Department of Health and Human Services recognizes Magee in Pittsburgh as a National Center of Excellence in Women’s Health; U.S. News & World Report ranks Magee nationally in gynecology. The Magee-Womens Research Institute was the first and is the largest research institute in the U.S. devoted exclusively to women’s health and reproductive biology, with locations in Pittsburgh and Erie.