FDA removes warning labels on hormone replacement therapy

On November 10, 2025, the FDA took historic action by announcing plans to remove the black box warning on hormone replacement therapy (HRT) for menopause.¹

The agency specifically noted that they are working with companies to update the language on HRT to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. However, they added, “The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.”

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Health and Human Services Secretary Robert F. Kennedy Jr., in the news release from the FDA.¹ “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”

This announcement follows a panel discussion in July in which experts urged the FDA to update the warning labels on HRT, arguing that the risks of adverse effects may be overstated. These warnings were initially added in the early 2000s after data from the Women’s Health Initiative study found a statistically non-significant increase in the risk of a breast cancer diagnosis among those who received the study treatment—a hormone formulation no longer commonly used.

Remarks from the expert panel, along with a review of a literature and a public comment period, led the FDA to remove what it called “misleading FDA warnings on hormone replacement therapy.”

“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,” said FDA Commissioner Marty Makary, MD, MPH, in the news release.¹ “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”

Updated data on HRT not only support its safety in menopausal women, but also indicate its potential protective effect in this population. In fact, the agency cited data showing that when initiated within 10 years of perimenopause, HRT may reduce the risk of cardiovascular diseases by 25% to 50%, reduce the risk of Alzheimer’s disease by 35%, and reduce the risk of bone fractures by 50% to 60%.

“Estrogen is a key hormone for women's health. Every single part of a woman's body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles,” said Advanced Research Projects Agency for Health Director Alicia Jackson, Ph.D. “The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives.”

REFERENCE

1. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-0