FDA Removes Black Box Warnings from Menopause Hormone Therapy: What Patients Need to Know

The U.S. Food and Drug Administration recently made a significant regulatory change that affects millions of women experiencing menopause symptoms. On November 10, 2025, the agency announced it would ask companies to remove most "black box" safety warnings from hormone drugs commonly used to treat menopause symptoms. This decision marks a major shift in how these medications are viewed by regulators and represents the culmination of years of advocacy from gynecologists, patients, and professional medical organizations.

Understanding the Regulatory Change

The FDA first required black box warnings on hormone therapy medications in 2003 following results from a large study that raised concerns about increased risks of breast cancer, stroke, and heart attack. These warnings, which represent the FDA's strongest safety alert, had a dramatic impact on patient willingness to use these treatments and led to a significant decrease in prescriptions. However, the science behind these warnings has evolved considerably over the past two decades.

The original study that prompted the warnings included mostly women older than 60 and used hormone formulations and delivery methods different from what's commonly prescribed today. More recent scientific research has demonstrated that these medications are much safer than previously believed, especially for women under 60 or those who had their last menstrual period within the last 10 years.

Types of Menopause Hormone Therapies

Menopause hormone therapy, sometimes called hormone replacement therapy or HRT, refers to medications prescribed to treat common menopause symptoms including hot flashes, night sweats, mood swings, and vaginal dryness. These treatments work by replenishing hormones such as estrogen and progesterone that naturally diminish during the transition to menopause.

Local Estrogen Therapy

Local estrogen therapies come in creams, rings, and tablets designed for application to specific areas, typically the vagina. These treatments address symptoms such as vaginal dryness, itching, urinary tract infections, and sudden urges to urinate. Because the hormones are absorbed into the bloodstream only in trace amounts, local therapies represent a low-risk option. However, their localized action means they cannot treat broader symptoms like hot flashes or mood swings.

Systemic Hormone Therapy

Systemic hormone therapy is designed to circulate hormones throughout the bloodstream, offering whole-body benefits but carrying more risk as a result. These therapies can be administered orally or absorbed through the skin via patches, sprays, or gels. Systemic treatments include estrogen-only therapy, progesterone-only therapy, or combination estrogen-progesterone therapy. Women who have had their uterus removed typically only need estrogen, while those who still have their uterus must also take progesterone to protect against endometrial cancer.

Appropriate Candidates and Benefits

According to medical experts interviewed by PolitiFact, the best candidates for hormone therapy are women with menopausal symptoms who are under 60 or who had their last menstrual period within the last 10 years. However, any woman experiencing symptoms related to menopause should consider evaluation and treatment options. Women without symptoms generally do not need hormone therapy, as it's not recommended solely for health promotion.

The benefits of hormone therapy are substantial for symptomatic women. Treatment can stop hot flashes and night sweats, improve sleep quality, stabilize mood, relieve joint pain, and resolve vaginal dryness and pain. Many women also experience relief from recurrent urinary tract infections and frequent urination. Systemic therapy provides the additional benefit of preventing rapid bone density loss that typically accompanies menopause, reducing fracture risk and osteoporosis.

Understanding the Risks

The removal of black box warnings doesn't mean these medications are risk-free. Most symptomatic women can use local low-dose estrogen without significant risk, and many experts believe these forms should never have carried the warnings in the first place. Systemic hormone therapies carry more risk and require careful consideration and medical guidance.

Research shows that women taking combination estrogen and progesterone therapy have a small increased risk of breast cancer, particularly with prolonged use beyond four to five years. However, newer hormone formulations appear more neutral for breast cancer risk than the formulas used in the original 2002 study. Some delivery methods also affect risk profiles—oral medications may increase blood clot risk while transdermal applications typically do not.

It's important to note that black box warnings for endometrial cancer will remain on estrogen-only systemic medications, and the FDA's decision doesn't change insurance coverage for most generic hormone therapy treatments.

Navigating Treatment Decisions

Choosing the right hormone therapy requires individualized consideration and thorough discussion with a healthcare provider. Women should seek providers comfortable with menopause medicine, and may consider using resources like The Menopause Society's certified provider search function to find qualified specialists. Preparing for appointments by listing symptoms in order of bothersomeness and understanding personal and family health history can help facilitate productive discussions about treatment options.

The FDA's decision to remove most black box warnings represents a significant step toward aligning regulatory guidance with current scientific understanding of menopause hormone therapy. While these medications aren't appropriate for everyone, they represent safe and effective options for many women suffering from menopausal symptoms when used under proper medical supervision.