FDA approves revised hormone therapy black box warning for menopause treatments

Posted on February 12, 2026

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Source: Healio

Key takeaways:

• The warnings related to CVD, breast cancer and probable dementia will be removed from six menopausal hormone therapy products.
• This is just the first batch of approved label changes, according to the FDA.

The FDA approved changes to the labels for six menopausal hormone therapy products in a move the agency said clarifies risk considerations for the drugs.

As Healio previously reported, the FDA initiated the warning removals in November 2025 after experts called for label changes during an FDA panel discussion in July 2025.

Since then, 29 drug companies have submitted proposed labeling changes, and the six products announced with approved labeling changes are just the first batch, according to a press release from the FDA. They include products from all four categories of hormone replacement therapy (HRT) for menopausal women: topical vaginal estrogen therapy, systemic estrogen-alone therapy, systemic combination therapy (estrogen and progestogen) and systemic progestogen-alone therapy for patients with a uterus using systemic estrogen.

The specific risk statements removed from the box warning were related to CVD, breast cancer and probable dementia, according to the release.

“This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” HHS Secretary Robert F. Kennedy Jr. said in a press release. “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy — free from exaggeration or fear. A health care 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, MD, MPH, said in the release that the changes will help people facing menopause “make well-informed medical decisions.”

“With today’s action, we are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” Makary said.

After hearing about the label changes, Holly L. Thacker, MD, FACP, CCD, NCMP, director of the Cleveland Clinic Center for Specialized Women’s Health and professor at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, praised the FDA’s decision and said she had been waiting for years for label changes to occur.

“This is in line with the published research and is evidence based,” Thacker told Healio. “There is nothing else we prescribe in medicine that has such profound effects on physical functioning and improving the health span and life span.”

Nanette Santoro, MD, professor and the E. Stewart Taylor Chair of OB/GYN at the University of Colorado School of Medicine, said she was surprised by a few aspects of the FDA’s announcement, with one of those being that transdermal estradiol was not included in the initial list of therapies that received a label change.

“Most worldwide clinical guidelines favor the use of non-oral estrogen to treat to menopausal symptoms and further favor naturally occurring estradiol over conjugated estrogens,” Santoro said. “The logic behind these guideline recommendations is based on observational [data], but not necessarily clinical trial data indicating a lower risk of venous thromboembolism among women using naturally occurring, non-oral estradiol. The data supporting that idea comes from a number of worldwide studies which are consistent.”

Santoro added that she was surprised to see no mention of an increased risk for thromboembolism on the label for combination estrogen plus progestin.

“Both estrogen alone and estrogen plus progestin seem to have increased risk of thrombolic events when given orally, but only estrogen alone was associated with an increased risk of stroke [according to] the Women’s Health Initiative,” Santoro said. “It’s not at all clear to me what data this statement is based on.”

Santoro said she was unsure whether these changes would have any impact on patients, as she believes most patients do not read the safety labels for HT products.

Thacker said she feels the changes may reassure patients and health care professionals who were unsure about menopausal HT safety in the past.

“I am hoping this reduces the exaggerated fear that prevented many women from taking menopausal HT and many clinicians from prescribing hormone therapy,” Thacker said.

For more information on the revised hormone therapy black box warning for menopause treatments, the history of the issue, expert insight and the science behind it all, read this feature.