WASHINGTON, D.C.—The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced on Monday, November 10, a series of measures aimed at updating guidance on hormone replacement therapy (HRT) for menopausal women, including the removal of longstanding “black box” warnings from certain 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,” Secretary Kennedy said at Monday’s press conference. He added that “bad science and bureaucratic inertia” had previously limited access to HRT, affecting both patients and physicians.
HRT, which typically includes estrogen and progesterone — or estrogen alone for women without a uterus — helps restore hormone levels that decline during menopause. This can alleviate common symptoms such as hot flashes, night sweats, sleep disruptions and bone density loss. Estrogen plays a critical role in multiple bodily systems, including the brain, bones, heart and muscles, according to Alicia Jackson, Ph.D., director of the Advanced Research Projects Agency for Health.
“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.”
Recent randomized studies support the therapy’s benefits when started early. Women initiating HRT within 10 years of menopause — generally before age 60 — show reduced all-cause mortality and fracture rates. Potential reductions include up to 50% in cardiovascular disease risk, 35% in Alzheimer’s disease and 50-60% in bone fractures. The FDA’s updated labeling will recommend beginning systemic HRT within this timeframe, with duration determined by individual patient-provider discussions.
The FDA approved a generic version of Premarin (conjugated estrogens), the first such approval in over 30 years for this long-established HRT. Officials expect the generic to enhance affordability and access without compromising quality, safety or efficacy.
Additionally, the agency greenlit a new non-hormonal medication for moderate to severe vasomotor symptoms, like hot flashes, offering an alternative for women who cannot or prefer not to use hormone-based treatments.
See FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products.
More information: FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
Author: Mario Lotmore
