In 2002, the Women’s Health Initiative (WHI) study reported increased risks of breast cancer, blood clots, stroke, and heart disease in women taking combined estrogen + progestin. The media coverage was intense, and many women stopped hormone therapy overnight. In response, the FDA issued a boxed (black box) warning in 2003 for all systemic estrogen products (pills, patches, gels, sprays, and rings).For many years, estrogen medicines used for hot flashes and night sweats have carried a black box warning. A black box warning is the strongest safety warning the FDA puts on a medication. This warning caused worry for many women and their physicians, and many avoided treatment even when their symptoms were affecting sleep, mood, work, and quality of life.

November 2025 the FDA announced that it will remove the black box warning from estrogen-containing menopausal hormone therapy products. This includes more than 20 pills, patches, and creams used to help with menopause symptoms such as hot flashes, night sweats, and vaginal dryness.

Why the Warning Is Changing

Newer research has shown something important:
Hormone therapy is safest and most helpful when it is started within 10 years of menopause, or before age 60.

Studies show that for many women in this age window, estrogen may actually have long-term health benefits, including:

• Better sleep
• Fewer hot flashes and night sweats
• Improved bone health
• Better quality of life

The older warning did not reflect this newer science. It was based on older studies that included many women who were more than 10 years past menopause, which is a time when the risks are higher. The updated labels will give more age-specific guidance to help women and doctors make informed decisions.

What This Means for Women

The removal of the black box warning does not mean hormone therapy is right for everyone. It means:

• Decisions should be individualized
• Benefits and risks should be discussed based on age, health history and risk factors, and symptoms
• Women in early menopause may have more benefit from menopausal hormonal therapy and lower risk from hormone therapy compared to women who start it many years later

Women with a history of breast cancer, blood clots, stroke, or certain other medical conditions will still need careful evaluation.

The Bottom Line

This change is a major step forward in women’s health. It recognizes what many menopause specialists and newer research have shown:
For the right woman, at the right time, hormone therapy can be safe, effective, and life-changing. Additionally, there are non-hormonal options for women who have contraindications to systemic estrogen.

If you are struggling with hot flashes, sleep disruption, or other menopause symptoms, please reach out. We can talk together about whether hormone therapy may be a safe and helpful option for you.

I hope this helps.