I Treat Menopause and Its Symptoms, and Hormone Replacement Therapy Can Help – Here’s the Science Behind the FDA’s Decision to Remove Warnings

November 27, 2025

After more than two decades of carrying FDA black box warnings about serious health risks, hormone therapy medications for menopause will have these safety labels removed following an FDA announcement on November 10, 2025. The warnings, added in 2003 after a Women's Health Initiative study suggested increased risks of cancer, heart disease, and dementia, led to a dramatic 46% drop in hormone therapy use within six months. Subsequent research over the past twenty years has revealed significant flaws in the original analysis and demonstrated that hormone therapy is generally safe, particularly for women under 60 or within ten years of menopause, with safety heavily dependent on timing, dosage, and delivery method.

Who is affected

Women going through menopause or postmenopause experiencing symptoms like hot flashes, night sweats, brain fog, vaginal dryness, painful sex, and urinary issues
Women who missed the optimal timing window for hormone therapy (those who went through menopause 10-15 years ago)
Younger menopausal women (under 60 or within 10 years of final period) who are safest candidates for systemic hormone therapy
Health care providers, including general practitioners who lack menopause-specific training and women's health specialists
Drug manufacturers who must remove the black box warnings
Women's Health Initiative study participants

What action is being taken

The FDA is asking drugmakers to remove black box safety warnings from both systemic and topical hormone therapy products for menopause
Researchers are conducting reanalyses of Women's Health Initiative data and newer studies
Women's health experts have been increasingly vocal in calling for removal of warnings, particularly for topical products
Clinicians specializing in women's health and menopause are safely prescribing hormone therapy based on current research

Why it matters

This decision is significant because the black box warnings, based on flawed analysis and outdated evidence, have prevented millions of women from accessing safe and effective treatment for debilitating menopause symptoms for over 20 years. The warnings particularly impacted topical vaginal estrogen therapy, which treats genitourinary syndrome of menopause affecting every person with ovaries who goes through menopause, despite never being studied in the original research and being extremely safe. The change will reduce anxiety among both clinicians and patients, potentially improving quality of life for women experiencing menopause symptoms, while also addressing the fact that many women missed the optimal timing window due to unwarranted fears. Additionally, the removal acknowledges important nuances in hormone therapy safety, including the timing hypothesis showing treatment is much safer for younger menopausal women and that delivery methods like patches carry lower risks than oral pills.

What's next

No explicit next steps stated in the article

Read full article from source: The San Diego Voice & Viewpoint