On Monday, Nov. 10, 2025, the U.S. Food and Drug Administration announced it will request drug makers remove the long-standing “black box” (boxed) warning on many estrogen-containing hormone therapies used for menopausal symptoms. The agency said the change follows a reappraisal of the evidence and is intended to expand safe treatment options for women, particularly those younger than 60 or within 10 years of menopause. Regulators and clinicians cautioned that some groups — for example, women with a history of hormone-sensitive cancer or clotting disorders — still face important risks. The move is expected to broaden prescribing and could prompt a surge in new prescriptions for midlife women nationwide.
Key Takeaways
- The FDA announced on Nov. 10, 2025, it will ask manufacturers to remove the boxed warning from many estrogen-containing menopause therapies, including pills, patches, sprays and creams.
- The boxed warning has been on these products since 2003 after the Women’s Health Initiative (WHI) results; the WHI trial participants had an average age of 63 when therapy began.
- Prescriptions for menopausal hormone therapy fell by more than 70% after the 2003 labeling change; in the late 1990s over 25% of postmenopausal women used hormones versus about 4% by 2020.
- FDA and specialists say hormone therapy is generally supported for women younger than 60 or within 10 years of menopause, but contraindications remain for those with prior hormone-sensitive breast or uterine cancer or increased clot risk.
- The agency convened an advisory panel in July 2025 that recommended removing the boxed warning; public-health and state-level policy efforts on menopause care have accelerated in parallel.
- Experts told CNN the label change could address longstanding undertreatment of disabling menopausal symptoms such as severe hot flashes, sleep disturbance and mood disruption.
Background
Boxed warnings are the FDA’s strongest labeling tool. In 2003, after initial findings from the Women’s Health Initiative — a large, government-funded randomized trial — regulators added a boxed warning to estrogen-containing products that noted elevated risks of cardiovascular events, stroke, venous thromboembolism and some cancers, and included concerns about dementia for women over age 65. The average age of WHI participants who started therapy was 63, meaning many began hormones well after menopause had started.
The immediate consequence was a sharp decline in prescribing. Following the 2003 label change, clinicians became more cautious and prescriptions for menopausal hormone therapy fell by roughly 70% by later analyses. In the late 1990s more than one in four postmenopausal women used hormone therapy; by 2020 that figure had fallen to about one in 25 in some studies. Advocates and some clinicians say the decline produced widespread undertreatment of symptoms that can substantially reduce quality of life in midlife.
Main Event
On Nov. 10, 2025, FDA Commissioner Dr. Marty Makary published an opinion and the agency moved to ask manufacturers to strip the boxed warning from many estrogen products used for menopause symptoms. The request follows months of internal review, external expert input and a July panel meeting where specialists urged the agency to remove the label. The FDA emphasized that the change is not a blanket approval for all women but a recalibration of how risks are presented on product labels.
Agency officials reiterated clinical nuance: current guidance supports considering hormone therapy for symptomatic women under 60 or within a decade of menopause onset, with individualized risk assessment. The FDA and many clinicians stressed that specific contraindications remain, including a history of hormone-sensitive breast or uterine cancer and conditions that increase blood-clot risk. Regulators said label language will be revised to better reflect age- and timing-dependent risk profiles documented in later analyses of the WHI and other studies.
Physicians and patient advocates described the decision as likely to expand access. Several experts told CNN they expect more primary-care and gynecology clinicians to reintroduce hormone options to eligible patients, and analysts forecast a rise in prescriptions. State-level activity has mirrored the federal reassessment: as of late 2025, 19 states had pursued more than 35 legislative measures addressing menopause care, insurance coverage, clinician training or workplace accommodations.
Analysis & Implications
Clinically, the change recognizes a growing consensus that timing matters. Re-analyses of WHI and other data since about 2010 have suggested that initiating estrogen closer to menopause and in younger women produces a different risk–benefit balance than starting therapy in older women. For many symptomatic midlife women, the potential benefits—relief from hot flashes, improved sleep and quality of life—are significant and, for appropriately selected patients, may outweigh measured risks.
Public-health effects could be substantial. If prescribing rebounds toward pre-2003 levels for eligible women, more women may receive symptom control that improves daily functioning and productivity; however, any rise in use will require careful clinician counseling to reduce avoidable harms. Insurance coverage and workplace policies enacted in many states may amplify uptake, making access less dependent on individual resources or local clinician practice patterns.
There are economic and research implications as well. A broader market for menopausal therapies could spur development of new formulations and encourage comparative-effectiveness studies focused on age, route of administration (oral vs. transdermal), and combinations of estrogen with progestogens. Regulators and specialty societies will likely update practice guidance and risk-communication materials to ensure patients and clinicians can make informed, individualized decisions.
Comparison & Data
| Metric | Late 1990s | 2020 | Change |
|---|---|---|---|
| Postmenopausal women using hormones | >25% | ~4% (1 in 25) | Down ~>70% |
| Average age of WHI therapy initiators | 63 years | ||
| States with menopause-related bills (as of 2025) | 19 states, >35 bills | ||
The table summarizes key prevalence figures and policy activity. The >70% fall in prescriptions tracks changes in clinician behavior and patient perception after the 2003 boxed warning. Re-analyses of WHI data and newer observational studies underpin the current view that age and timing of initiation are central modifiers of risk.
Reactions & Quotes
FDA leadership framed the change as correcting a label that had unduly deterred many appropriate users. Commissioner Makary has argued publicly that the boxed warning led to widespread avoidance of therapy for eligible women and used opinion venues to press for removal.
“These are the strongest drug warnings the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment.”
Dr. Marty Makary, FDA Commissioner (opinion piece)
Clinicians who treat menopausal symptoms described the decision as long-awaited, saying their patients frequently report receiving mixed messages about safety. Some specialists emphasized the need for tailored risk assessment rather than blanket advice.
“I am begging the FDA, and all of us are begging, please remove the box label. And please stop harming women.”
Dr. JoAnn Pinkerton, University of Virginia (advisory panel)
Patient advocates and some physicians noted the action should be paired with education so women understand who benefits and who remains at risk. Some clinicians warned that simplified messaging could lead to inappropriate therapy if contraindications are overlooked.
“Hormone therapy can help women with severe symptoms, but it must be used with individualized counseling about risks like prior hormone-sensitive cancer or clotting disorders.”
Dr. Jayne Morgan, cardiologist and women’s health researcher
Unconfirmed
- The exact magnitude and speed of the prescription increase after label removal are uncertain and will depend on clinician practice patterns and insurer coverage.
- Estimates cited in public commentary—such as Commissioner Makary’s figure that 50 million women were denied therapy—are broad approximations that require further validation with longitudinal prescribing data.
- Long-term outcomes from a renewed large-scale uptake (for example, decade-long population-level effects on cancer or dementia rates) remain to be observed and monitored.
Bottom Line
The FDA’s request to remove boxed warnings from many estrogen-containing products marks a major regulatory shift that reflects more granular evidence about age- and timing-dependent risks. For symptomatic women under 60 or within 10 years of menopause, clinicians now have clearer regulatory latitude to consider hormone therapy as a valid option, provided individual risk factors are assessed.
However, the change is not risk-free: women with prior hormone-sensitive cancers, clotting disorders or other contraindications must still avoid or carefully weigh therapy. The transition will require updated clinician guidance, insurer responses, and active patient education to ensure that broader access translates into safer, better-managed care rather than indiscriminate use.
Sources
- CNN (media coverage of FDA announcement)
- U.S. Food and Drug Administration (official press and regulatory information)
- The Wall Street Journal (opinion by FDA Commissioner Marty Makary)
- Women’s Health Initiative (WHI) (government-funded clinical trial information)
- The North American Menopause Society (professional society guidance and petitions)
- Birnbaum Women’s Leadership Center, NYU (advocacy and policy tracker)