FDA to remove boxed warnings from hormone therapies for menopause

The US Food and Drug Administration (FDA) on Monday announced its plan to remove the boxed warnings for menopausal hormone therapies (MHT), commonly referred to as hormone replacement therapy (HRT), following the recommendation of an expert panel convened by the agency in July.

These products treat menopause symptoms, such as hot flashes and night sweats, as well as issues related to changes in the vagina, vulva, and urinary tract caused by decreased estrogen. Some hormone therapies are also approved for preventing osteoporosis. The agency is also updating language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia associated with these treatments.

This action was announced by Health and Human Services Secretary Robert Kennedy Jr. and FDA Commissioner Marty Makary during a press conference on Monday.

Kennedy said that prior to a 2002 study, which linked use of HRTs to an increased risk of cardiovascular disease and breast cancer, one in four women with menopause used HRTs. However, after the study was published, the number dropped to fewer than one in 20. “That is not progress, that is neglect, that is malpractice. We can no longer accept a culture of fear that blocks innovation and keeps patients from using proven therapies,” Kennedy stated.

Makary also questioned the validity of the 2002 study, which was funded by the National Institutes of Health and conducted by the Women’s Health Initiative (WHI). He said that “tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk.” The study was largely discredited because it focused on a narrow segment of women using HRTs, failing to consider the broader population of HRT users.

FDA required the boxed warnings, which identified an increased risk of breast cancer, blood clots, and strokes for patients using certain hormone therapies, after the 2002 study was published. As a result, many physicians were cautious about prescribing these treatments.

At the press conference, urologist Kelly Kasperson said that “today marks a monumental shift in women’s health. The FDA has finally acted to correct misleading guidance [on HRTs].”

A July 2025 advisory committee panel convened by FDA Commissioner Marty Makary dismissed the 2002 study and recommended lifting these black box warnings. (RELATED: Panel urges FDA to remove boxed warning on women’s hormone therapy, Regulatory Focus 17 July 2025)

FDA is now recommending the elimination of language related to cardiovascular diseases, breast cancer, and probable dementia from the boxed warning, as well as the removal of language related to endometrial cancer, except in the systemic estrogen-alone drugs. Additionally, the agency is recommending the removal of a recommendation to use the lowest effective dose for the shortest amount of time and the removal of the warning regarding probable dementia from the label.

The agency recommends that the labeling for systemic hormone therapy products suggest initiating treatment for moderate to severe night sweats in women under 60 or within 10 years of the onset of menopause. It also advised maintaining the boxed warning that links systemic estrogen-only products to endometrial cancer, as well as retaining warnings regarding cardiovascular diseases and breast cancer.

For local vaginal estrogen products, FDA recommends condensing safety information and prioritizing information most relevant to the local vaginal formulation.

FDA also announced that it has approved two new medications for menopause: a generic version of Premarin, marking the first such approval for hormone replacement therapy in over 30 years, and a non-hormonal treatment for hot flashes. This option is for women who cannot or choose not to use hormone therapy.

Announcement; FDA announcement on labeling changes

FDA to remove boxed warnings from hormone therapies for menopause

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