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iStock, SiberianArt After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.” The FDA will remove the black box warning on all hormone replacement therapies, reversing a 22-year-old decision Health Secretary Robert F. Kennedy Jr. characterized in a press conference Monday morning as the American medical establishment “turn[ing] its back on women.” “Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause,” Kennedy said, standing alongside FDA Commissioner Marty Makary, Second Lady Usha Vance and other government representatives and physicians. “That ends today.” The black box warning—the strongest the FDA can levy on a product—for hormone replacement therapies (HRT) stemmed from a 2002 landmark study called the Women’s Health Initiative (WHI) that found an increased risk of heart disease and breast cancer associated with the class of drugs. In a statement Monday, the Department of Health and Human Services noted that this increase was “statistically non-significant” and pointed out that the average age of its participants was 63 years, “over a decade past the average age of a woman experiencing menopause,” according to the agency. The global HRT market was estimated to be nearly $24 billion in 2024 and is projected to reach nearly $40 billion by 2033, with North America accounting for the largest share and Asia Pacific the fastest growing market, according to Grand View Research . Leading pharma players are Bayer, Pfizer, Ascendis Pharma and Novartis Gene Therapies. The FDA’s decision follows the convening of an expert panel on menopause and hormone replacement therapy in July. This represents a new format for the agency during which an “independent panel of scientific experts” will “review the latest scientific evidence, evaluate potential health risks, explore safer alternatives” and possibly offer recommendations for regulatory action. The panel faced criticism over apparent bias, with Diana Zuckerman, president of the nonprofit National Center for Health Research, telling BioSpace in September that she was struck by the lack of nuance presented during the session, as well as a later panel focused on SSRI use during pregnancy. During Monday’s press conference, Kennedy listed a number of statistics, including that HRT has been found to reduce the risk of cardiovascular disease and mortality by as much as 50%, Alzheimer’s disease by 35% and bone fractures by 50–60%. Kennedy claimed these factors combined could “extend [women’s] lives by as much as 10 years.” Makary, who called Monday a “historic day for women in the United States,” added that women who took estrogen alone in fact had a 24% reduction in breast cancer. A breast cancer research page attributing this stat to the WHI notes a 23% reduction in breast cancer diagnoses and adds that women taking estrogen-only HRT are 44% less likely to die from the disease. Prior to 2002, one in four American women used hormone replacement therapy, Kennedy claimed. Today, he said, that number is fewer than one in 20. “That’s not progress, that’s neglect, that’s malpractice. We can no longer accept a culture of fear that blocks innovation and keeps patients from proven therapies.” In related news, the FDA recently signed off on Bayer’s oral therapy Lynkuet for moderate to severe hot flashes in menopausal women. Lynkuet is the first FDA-approved therapy that blocks both the neurokinin 1 and neurokinin 3 receptors to treat this common symptom of menopause.

The Food and Drug Administration plans to discard warning labels for hormone therapies for menopausal women, undoing decades-old language cautioning that treatments may increase the risk of cancer or heart disease.In a statement Monday, the FDA said it is initiating the removal of boxed warnings for all hormone replacement therapies, or HRTs. That announcement was issued alongside a press conference from the U.S. Department of Health and Human Services as well as an op-ed FDA Commissioner Martin Makary published in the Wall Street Journal. The decision was issued following a comprehensive review of the scientific literature, feedback from an expert panel in July, and a public comment period, the agency said.Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life's most difficult transitions, menopause. That ends today, HHS Secretary Robert F. Kennedy Jr. said during the press conference.HRT can provide relief from the vasomotor symptoms, or hot flashes, in women going through menopause. But its not always prescribed because of black box warnings the agencys most severe alerting clinicians of an increased risk of cancer and cardiovascular events. The FDAs current labeling also cautions against using estrogen for the prevention of cardiovascular disease or dementia.The labeling originated from a study conducted by the Womens Health Initiative and that evaluated the use of estrogen plus progestin in postmenopausal women. The study was stopped early in 2002 after investigators detected an increased risk of breast cancer and heart disease. Two years later, another arm of the trial evaluating only estrogen was also stopped early due to a higher risk of stroke.Other study results have pointed to more mixed or even positive effects not only on hot flashes and night sweats, but heart health and the likelihood of bone fractures or Alzheimers disease, leading to years of intense debate about the benefits and risks of HRT. Some medical associations support broad use, but still note risks and suggest discussions with physicians.Makary, for his part, has long been critical of the safety warnings for HRT and argued for broader use. In his 2024 book Blind Spots, Makary questioned the evidence supporting a link to cancer and contended multiple long-term benefits were being overlooked. A 12-member panel he convened in July all held similar views and called for HRTs labeling to be updated.In my professional opinion, the demonization of hormone replacement therapy for perimenopausal women and the underappreciation of its health benefits ranks among the greatest mistakes of modern medicine, Makary wrote in the op-ed Monday.Still, the decision was made in an unorthodox fashion. Julys panel was an informal discussion, not the typical FDA advisory committee that rigorously reviews new safety data. Public comments were also only allowed afterwards.When asked about the FDAs decision not to convene an advisory panel, Makary said those committees are bureaucratic, long, often conflicted and very expensive.We can have an active, robust discussion as a group of medical experts spontaneously, so we're doing more of that, he said.Makary added that the panelists in July conducted a comprehensive review of the scientific literature and came to the conclusion the FDA accepted.Alongside its announcement, the FDA also approved two treatments: a generic version of Premarin for menopausal symptoms, and a non-hormonal therapy for hot flashes. '