FDA Removes Black Box Warnings From Hormone Replacement Therapy Products

In November 2025, the U.S. Department of Health and Human Services announced it was removing black box warnings from menopausal hormone replacement therapy (HRT) products. This change comes “after more than two decades of fear and misinformation” surrounding HRT, the Food and Drug Administration — a division of the HHS — stated in a news release reversing its own censure.

In supporting this radical shift, the HHS cites numerous studies — some dating as far back as four decades — in a fact sheet outlining the decision, suggesting that “starting HRT within 10 years of the onset of menopause can have numerous benefits which for most women outweigh potential risks.”

Women have long used HRT to relieve menopausal symptoms. But demand fell in the early 2000s when the FDA applied the warnings following a Women’s Health Initiative study that associated HRT with an increased risk of a breast-cancer diagnosis — even though that increase was statistically insignificant, the FDA now says.

Benefits of HRT, the HHS states, include a reduced risk of bone fractures and all-cause mortality, a 50 percent reduction in heart-attack risk, a 64 percent reduction in cognitive decline, and a 35 percent lower risk of Alzheimer’s.

“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,” notes Alicia Jackson, PhD, director of the HHS’s Advanced Research Projects Agency for Health, in the news release. “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.”

Still, HRT is not right for everyone. Women with a history of breast cancer may want to avoid systemic HRT: Previous studies have found that the treatment significantly increased the risk of breast-cancer recurrence — especially in patients with hormone receptor-positive disease, the most commonly diagnosed subtype of breast cancer.

Yet risk level varies based on a person’s circumstances, medical history, and HRT type. Those experiencing discomfort from menopausal symptoms should consult with their provider to make an informed decision on HRT use based on their situation and goals.