FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

Lead

The Food and Drug Administration announced Monday it will remove the 22-year-old boxed warning from more than 20 estrogen- and progestin-containing pills, patches and creams used to treat menopause symptoms such as hot flashes and night sweats. Officials said new analyses show lower cardiovascular and cognitive risks when hormone therapy is begun before age 60 or within 10 years of menopause. The agency will keep a boxed warning requiring combined estrogen–progestin for women who still have a uterus, to reduce the risk of uterine lining cancer. The decision drew praise from some clinicians and sharp criticism from others over the advisory process.

Key takeaways

• The FDA will strip the boxed warning from 20+ hormone therapy products, the agency announced Monday; the original warning has been in place for 22 years.
• Officials cited evidence that hormone therapy started before age 60 or within 10 years of menopause carries fewer heart and dementia risks than earlier analyses indicated.
• The boxed warning language will remain on the label for the cancer risk tied to using estrogen alone in women with an intact uterus; combined estrogen–progestin is still recommended in those cases.
• The 2002 landmark study of >26,000 women had linked some oral hormone pills to increased stroke, blood clots and breast cancer, prompting a sharp decline in prescriptions in the 2000s.
• FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr. supported the change; a group of nearly 80 researchers and some scientists criticized the agency’s advisory process.
• Newer, lower‑dose local formulations (vaginal creams, tablets) and non-oral delivery methods have entered the market since the early 2000s and differ in systemic exposure.

Background

In the 1990s more than one in four U.S. women used estrogen alone or combined estrogen–progestin therapies, in part because early hope suggested benefits beyond symptom relief—potential protection against heart disease and dementia. That confidence collapsed after a large randomized trial in 2002 involving more than 26,000 women reported higher rates of stroke, venous thromboembolism and breast cancer for some hormone regimens, prompting the FDA to place the strongest safety advisory—a boxed warning—on estrogen products.

Over the following decades clinicians and researchers re-examined the evidence and noted heterogeneity by age, timing of initiation and formulation. Observational findings and subsequent re-analyses suggested that risks differ substantially for younger postmenopausal women starting therapy close to menopause versus older women beginning treatment later. Meanwhile, pharmaceutical innovation produced patches, transdermal systems and low-dose local preparations that produce lower circulating hormone levels than older oral pills.

Main event

On Monday the FDA said it will move the most alarming language from the top of labels for more than 20 hormone-containing products and will no longer present the blanket boxed warning that linked hormone therapy to stroke, heart attack and dementia. Agency officials pointed to newer analyses showing that women who begin treatment before age 60 or within a decade of menopause generally face minimal cardiovascular risk compared with older initiators.

Health Secretary Robert F. Kennedy Jr. framed the change as an effort to update labels to reflect current science. FDA Commissioner Marty Makary described the previous language as outdated and said removing the box will facilitate individualized, evidence-based decisions between physicians and patients. The agency emphasized that the full original boxed-warning text will remain accessible in prescribing information, but placed lower in the label.

Critics focused less on the science than the process. Rather than convening a standing advisory panel on women’s health or drug safety, the FDA earlier this year invited a small, hand-picked group of clinicians and researchers—many of whom prescribe or consult for industry—to a meeting that broadly favored expanding access. Nearly 80 researchers later asked the agency to hold an official advisory committee meeting to publicly scrutinize the evidence.

Analysis & implications

Removing the boxed warning will likely increase the number of patients and clinicians willing to consider hormone therapy for symptomatic relief, especially among younger postmenopausal women. Because the majority of clinical guidelines already endorse limited-duration hormone therapy for otherwise healthy women under about 60, the label change mainly aligns federal labeling with contemporary guideline language and emerging age-stratified evidence.

However, the policy shift is not purely clinical; it has regulatory and trust consequences. Critics argue that bypassing an open advisory committee risks the FDA’s perceived neutrality and could fuel public skepticism when process transparency is valued for contentious safety decisions. The agency’s credibility may hinge on how clearly it communicates the age-, timing- and formulation-specific nuances that the public must understand.

From a public‑health lens, a label that better differentiates risk by age and delivery method could reduce unnecessary avoidance of beneficial therapy while preserving safeguards for higher‑risk groups. Yet uncertainties remain about long-term outcomes such as cancer and cognitive decline for varying regimens and patient profiles, so clinicians will still need to weigh individual risk factors—breast cancer history, thrombotic risk, cardiovascular disease—and to counsel patients on alternatives and duration limits.

Comparison & data

The table summarizes broad findings referenced by FDA officials: the original 2002 trial detected increased risk signals across pooled participants, while later subgroup analyses suggested benefit-to-risk profiles that vary by age at initiation. Newer, low-dose and local products were not the primary focus of the 2002 trial, complicating direct comparisons.

Reactions & quotes

Regulatory and professional leaders offered contrasting takes. Supporters said the change will allow better patient-centered care; critics questioned the advisory process.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.”

Robert F. Kennedy Jr., U.S. Health Secretary

Kennedy used the announcement to frame the label revision as a correction of overly cautious language that has deterred appropriate use. His comments reflected the administration’s public messaging that the updated label will let clinicians make more individualized decisions.

“That study was misrepresented and created a fear machine that lingers to this day.”

Marty Makary, FDA Commissioner

Marty Makary reiterated longstanding criticisms of how the 2002 evidence was communicated and argued the agency’s action restores balance. Makary and other supporters have pointed to analyses suggesting population-level gains if younger symptomatic women receive timely hormone therapy.

“The black box is really one size fits all. It scares everyone away.”

Dr. JoAnn Manson, Harvard Medical School (expert commentary)

Manson cautioned that while removing the warning could prompt more tailored conversations, the evidence of broad cardioprotective or cognitive benefits remains less definitive than some advocates claim.

Unconfirmed

• Claims that hormone therapy universally reduces heart disease and Alzheimer’s disease at the population level remain unsettled and are subject to ongoing study.
• Allegations that the FDA deliberately avoided full scientific scrutiny by not convening a standing advisory committee are contested; calls for a public advisory meeting from nearly 80 researchers had been reported but the agency proceeded without it.

Bottom line

The FDA’s decision to remove the long-standing boxed warning recognizes a more nuanced evidence base indicating lower cardiovascular risk for women who start hormone therapy before age 60 or within 10 years of menopause. For symptomatic, otherwise healthy younger postmenopausal women, this change could expand access to therapies many clinicians consider safe for limited-duration use.

Yet the move also spotlights tensions between updating labels to reflect new evidence and maintaining transparent, independent review processes for contentious safety questions. Patients and clinicians should continue individualized risk assessment—considering age, cardiac and clotting history, breast cancer risk and formulation—while regulators and researchers pursue longer-term data on cancer and cognitive outcomes.

Sources

• Associated Press (news report summarizing FDA announcement and reactions)
• U.S. Food and Drug Administration (official regulatory announcements and label information)
• American College of Obstetricians and Gynecologists (professional society statements and clinical guidance)