When the US Food and Drug Administration announced in November 2025 that it would remove long-standing black box warnings from many menopausal hormone therapy (HRT) products, it was more than a regulatory footnote. It was an end to two decades of fear that shaped how doctors and women approached midlife care.
The agency said the decision follows a comprehensive review of recent science and expert advice, and that labels will be updated to remove blanket cautions about heart disease, breast cancer, and probable dementia. Some warnings (for example, about endometrial cancer with estrogen-only systemic therapy in women with a uterus) will remain.
This matters in India because there are well over 100 million women in the midlife age bands most affected by menopause. This cohort stands to gain from changes in how HRT is now perceived and used. Women aged roughly 40–64 make up a substantial share of the population, for whom stigma, misinformation, and patchy access could translate into preventable poor health in later life.
The Fear Around HRT
The fear around HRT traces back to a trial from the early 2000s by Women’s Health Initiative (WHI), which found increased risks of heart disease, stroke and breast cancer in an older cohort of women taking combined estrogen–progestin therapy. That finding led to the boxed warnings and a generation of caution. But subsequent re-analyses, follow-ups and newer trials have shown that timing matters. When hormone therapy is begun before age 60 or within ten years of menopause onset, the balance of risks and benefits appears different. There are reduced cardiovascular events, fewer hip fractures, and possible cognitive benefits in some analyses. This ‘timing hypothesis’ is central to why regulators are rethinking warnings.
Myths Vs Facts
Myth: HRT will definitely give me breast cancer and heart attacks.
Fact: Risks depend on age at initiation, type of hormones, dose and route, which could be oral, patch or vaginal. Starting HRT early in menopause shows different risk profiles than starting it later. Low-dose local vaginal estrogen has negligible systemic absorption.
Myth: HRT is just for hot flashes.
Fact: Symptom relief is the primary indication, but HRT can also improve bone density and may have cardiovascular and cognitive benefits when used in the right window for the right patient.
Gaps And Taboos
In India, menopause is frequently shrouded in silence. Many women tolerate disabling hot flashes, sleep disruption, mood changes and genitourinary symptoms without seeking care because of stigma, lack of awareness, or a belief that midlife decline is inevitable. Doctors and gynecologists in many parts of the country may also be conservative because of fears seeded by earlier warnings.
Untreated menopausal symptoms reduce quality of life, workplace productivity, and can accelerate bone loss that leads to fractures. This is especially a major driver of disability in older women. HRT, used appropriately, prevents fractures or reduces cardiovascular risk for some women. This represents a major opportunity for improving healthy ageing among India’s middle-aged women.
Caveats And Safety
That being said, HRT cannot be prescribed to everyone. The evidence supports individualised, informed decision-making and is not a blanket green light. Some risks remain, including endometrial cancer risk. Women with a personal history of breast cancer, high thrombotic risk, or uncontrolled liver disease may not be ideal candidates. The form of therapy also matters. Transdermal estrogen may carry lower clot risk than some oral forms. Combined therapy carries different breast cancer signals than estrogen alone. Local vaginal estrogen is safe and effective for genitourinary symptoms with minimal systemic effect. Clinicians must weigh personal risk, comorbidities, family history, and patient preferences.
What Can Policy Makers Do?
Update national guidelines: The Ministry of Health and state health authorities should review and update menopause care guidance to reflect the timing hypothesis and risk–benefit evidence.
Train the frontline: Integrate menopause modules into medical and nursing curricula so general practitioners can counsel women appropriately.
Public information campaigns: Normalise menopause conversations, counter myths, and promote symptom screening at routine health visits and women’s wellness camps.
Ensure access and affordability: Include essential HRT formulations and bone-health medications where appropriate in public procurement lists and insurance schemes.
Collect Indian data: Support trials in Indian populations to monitor outcomes, as most global evidence is from high-income settings.
Femtech And Private Sector Contributions
Femtech firms and private clinics can bridge awareness and gaps by creating culturally sensitive education platforms in local languages and telemedicine consultations with menopause specialists. There should be affordable options like patches or low-dose vaginal therapy for lower-income women. Startups can partner with government programs to reach rural women and fund community health-worker training.
The FDA’s move removes a regulatory alarm bell that steered many women away from a therapy for 20 years. But when started at the right time, using the right dose and in the right person, HRT can do more than ease hot flashes. For India’s 100-plus-million midlife women, the change is welcome. Although it will require better guidelines, clinician training, public education, affordable access, and culturally aware tech, it also means healthier bones, better sleep and mood, and the possibility of fewer heart ailments as women age.