Brain Health News

FDA Removes Black Box Warnings on Hormone Replacement Therapy

Bottom Line: The FDA is removing black box warnings from HRT products after comprehensive scientific review. 

What happened: On November 10, 2025, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced the FDA is initiating removal of boxed warnings from HRT products following comprehensive review of scientific literature, an expert panel in July, and a public comment period.

Why the original warnings were misleading: The Women's Health Initiative study had important limitations:

• Average participant age was 63 years—over a decade past typical menopause age
• Used hormone formulations no longer in common use
• Found only a statistically non-significant increase in breast cancer risk

What the science shows: Women who initiate HRT within 10 years of menopause onset (generally before age 60) are associated with:

• Reduction in all-cause mortality
• Up to 50% reduction in cardiovascular disease risk
• Reduction in Alzheimer's disease risk (see Section 2)
• 50-60% reduction in bone fractures

What's changing: The FDA is working with companies to remove references to risks of cardiovascular disease, breast cancer, and probable dementia from product labels. The boxed warning for endometrial cancer for systemic estrogen-alone products remains.

Additional actions: The FDA is also approving the first generic version of Premarin in over 30 years (improving affordability) and a new non-hormonal treatment for moderate to severe hot flashes.

What This Means: This FDA decision is important because millions more women will now have access to updated, evidence-based guidelines to help facilitate informed conversations about a treatment option that may significantly benefit brain health when started at the right time.

Technique Spotlight

Hormone Replacement Therapy (HRT)

At BetterBrain, we consider HRT one of the highest-impact interventions for brain health in women navigating menopause.

The Science:Hormone replacement therapy (HRT) is commonly used to supplement declining hormone levels in post-menopausal women. Some hormones, like estrogen, appear to have a protective effect on the brain and may reduce inflammation and the accumulation of harmful proteins linked to neurodegenerative diseases, like Alzheimer's. By maintaining hormone levels throughout the critical menopause transition and beyond, HRT can reduce the risk of developing neurodegenerative disease.

Why We Prioritize HRT at BetterBrain

The evidence is compelling. While we need more randomized controlled trials, the observational evidence consistently points to significant brain health benefits when HRT is initiated during the menopause transition. The landmark Cache County Study found that women who used HRT for more than 10 years eliminated their sex-specific increased risk of Alzheimer's disease entirely—their risk became comparable to men's.

The impact can be substantial. The Cache County Study showed:

• 41% reduced Alzheimer's risk among all HRT users (adjusted HR 0.59)
• 67% reduced risk among former users who took HRT during menopause (adjusted HR 0.33)
• Complete elimination of women's excess Alzheimer's risk (compared to men) with 10+ years of use

The window doesn't stay open forever. This is perhaps the most important point: the protective benefits appear strongest when HRT is initiated within 10 years of menopause onset, typically before age 60. Starting too late (in your 60s or 70s) may not provide the same cognitive benefits. The brain benefits from continuous hormonal support during the transition, not replacement decades later.

HRT isn't right for everyone. Decisions should be individualized based on:

• Personal and family medical history
• Risk factors for breast cancer, blood clots, or cardiovascular disease
• Individual symptoms and quality of life
• Personal preferences and values

BetterBrain's Approach

When we assess hormone status in our clients, we evaluate whether they're within the critical timing window, assess individual risk factors, and provide evidence-based information to support informed conversations with their healthcare providers.

Partner Announcement

BetterBrain x The 'Pause Life

Dr. Mary Claire Haver's The 'Pause Life has become one of the most trusted voices in women's health and menopause. Her evidence-based approach to helping women navigate perimenopause and menopause which addresses everything from hormone health to metabolic changes, aligns perfectly with our mission at BetterBrain.

Dr. Haver understands the critical link between hormonal health and cognitive function during menopause, when dementia risk increases for women, which iswhy we're proud to partner with The 'Pause Life. Together, we're bringing cutting-edge brain health insights to her community, helping women optimize both hormonal and cognitive health during this crucial transition.

We're honored to be featured on The Pause Life's Brain Health Picks alongside other evidence-based resources for women's health.