FDA narrows boxed warnings for six menopausal hormone therapies

The Food and Drug Administration has approved labeling changes that remove specific boxed‑warning statements about cardiovascular disease, breast cancer and probable dementia from six menopausal hormone‑replacement therapy products, the agency announced Feb. 12, 2026. The revisions are the first tangible outcomes of a comprehensive safety review the agency began late last year.

The FDA framed the move as an effort to “clarify risk considerations for these drugs.” The agency said randomized studies show that women who begin hormone therapy within 10 years of menopause onset, generally before age 60, have reductions in all‑cause mortality and fractures. The changes apply to a first batch of six products that represent the four broad categories of menopausal therapies: topical vaginal estrogen, systemic estrogen‑alone, systemic combination estrogen and progestogen, and systemic progestogen‑alone used with systemic estrogen. The agency did not publish the full list of affected product names in its announcement.

The initiative follows a sequence of advisory and regulatory steps begun in mid‑2025. Experts at an FDA advisory panel in July 2025 urged changes to labeling, and the agency initiated a comprehensive literature review in November 2025. “At the FDA’s request, 29 drug companies have submitted proposed labeling changes,” the agency said, and this week it approved the initial six submissions. Officials have said the approvals are the first batch, with other submissions under review.

HHS Secretary Robert F. Kennedy Jr. praised the decision as evidence of the government following evolving science and changing guidance as evidence emerges. “This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” he said. “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.” FDA Commissioner Marty Makary added that the changes will help people facing menopause “make well‑informed medical decisions.”

Regulators emphasized that not all safety language was removed: the boxed warning for endometrial cancer will remain on systemic estrogen‑alone therapies. The agency also noted that the products approved for label changes cover the full range of clinical indications for menopausal therapies, including treatment of moderate‑to‑severe vasomotor symptoms such as hot flashes, treatment of vaginal dryness and discomfort, and prevention of bone loss.

Public‑health advocates and clinicians are likely to watch how the revised language affects prescribing and patient decision making. The FDA highlighted a striking utilization gap: in 2020, there were about 41 million U.S. women ages 45 to 64, yet only roughly 2 million women ages 46 to 65 received a hormone‑therapy prescription. Advocates say clearer risk messaging could reduce fear and misinformation that deter treatment, but experts also caution that labeling changes alone will not address barriers to care such as access, clinician time, insurance coverage and historical distrust of medical guidance.

Manufacturers and the agency will need to provide clinicians and patients with clear, accessible explanations of what the boxed‑warning changes mean in practice, and whether the revisions apply to all formulations and dosages of the approved products. The FDA signaled this action as a recalibration of messaging to reflect current evidence and indicated further label updates are expected as additional company submissions are reviewed.