WASHINGTON — In a sweeping reversal of two decades of medical caution, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced Monday that the FDA will remove broad “black box” warnings from hormone replacement therapy (HRT) products used to treat symptoms of menopause.
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The decision follows a comprehensive review of scientific evidence, an expert panel in July, and a public comment period. Officials say the move restores “gold-standard science” to women’s health after years of confusion and fear surrounding hormone therapy.
“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” said Health and Human Services Secretary Robert F. Kennedy Jr. “We are returning to evidence-based medicine and giving women control over their health again.”
The warnings, added in the early 2000s, stemmed from the Women’s Health Initiative study, which found a small increase in breast cancer diagnoses among participants receiving HRT. However, the FDA noted that the average age of women in that study was 63 — more than a decade older than the average age of menopause — and the hormone formulation used is no longer common.
According to the agency, the boxed warnings will be removed for risks related to cardiovascular disease, breast cancer, and dementia. A warning for endometrial cancer will remain for systemic estrogen-only products.
“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, M.D., M.P.H. “Women and their physicians should make decisions based on data, not fear.”
HRT, which provides estrogen and progesterone (or estrogen alone for women without a uterus), is used to relieve common menopausal symptoms such as hot flashes, night sweats, sleep problems, and bone loss. Research has shown that women who begin hormone therapy within 10 years of menopause onset — generally before age 60 — may see significant benefits.
According to the FDA, those benefits include reductions in all-cause mortality and fractures, as well as lower risks of cardiovascular disease and Alzheimer’s disease. “Women may also reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%,” the agency stated.
“Estrogen is a key hormone for women’s health,” said Alicia Jackson, Ph.D., director of the Advanced Research Projects Agency for Health. “Every single part of a woman’s body depends on estrogen to operate at its best — including the brain, bones, heart, and muscles. 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.”
The FDA also announced approvals of two new drugs to expand treatment options for menopausal women. The first is a generic version of Premarin (conjugated estrogens) — the first such approval in more than 30 years — which officials say will improve affordability and access. The second is a non-hormonal therapy for moderate to severe vasomotor symptoms, such as hot flashes, offering an option for women who cannot or choose not to take hormones.
“Someday, science will help us slow or reverse all the damage of aging,” said Deputy Secretary of Health and Human Services Jim O’Neill. “A good safe way to address estrogen depletion already exists, and today Secretary Kennedy and Commissioner Makary are removing a barrier on this treatment. Many more women can reduce their risk of fracture, heart disease, and immune and cognitive decline while extending their vigor.”
Sales of HRT products dropped sharply after the early 2000s warnings, leaving many women struggling with untreated symptoms. Advocates have long pushed for a reassessment of the risks and benefits, especially for women entering menopause at the typical age range of 45 to 55.
With Monday’s action, the FDA says it aims to bring the labeling for HRT in line with the latest evidence and encourage informed decision-making between patients and their physicians.
“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,” Kennedy said.
Always consult your own doctor to discuss HRT and menopause symptoms in general.
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