![\"A](\"https:\/\/www.newsbeep.com\/il\/wp-content\/uploads\/2025\/11\/d41586-025-03687-0_51692802.jpg\"\/)
<\/p>\n <\/p>\n
A ‘black box’ warning has appeared on hormone replacement therapies in the United States for more than 20 years.Credit: Getty<\/p>\n
On Monday, the US Food and Drug Administration announced its intention to eliminate safety warnings for hormone replacement therapy creams, pills and patches used to treat the symptoms of menopause. The move, which the FDA called \u201ca historic action<\/a> to restore gold-standard science to women\u2019s health\u201d, is drawing both praise and concern from scientists and advocates.<\/p>\n Many argue that the warnings, which have appeared on the products for more than 20 years, have contributed to chronic underuse of menopausal hormone therapy among women who were likely to benefit. Yet some now worry that removing the labels entirely, or making overly broad claims about hormones, health and longevity, might swing the pendulum too far in the opposite direction. \u201cI\u2019m afraid comprehensive discussion about the risks and benefits may not occur in absence of that warning,\u201d says Stephanie Faubion, the director of Mayo Clinic\u2019s Center for Women\u2019s Health in Jacksonville, Florida, and medical director of The Menopause Society a non-profit organization based in Pepper Pike, Ohio, that provides tools and resources to health-care professionals. \u201cWe need to end up somewhere in the middle.\u201d<\/p>\n Hormone crash<\/p>\n Hormone therapy was widely prescribed for decades to ease common menopausal symptoms such as hot flushes, night sweats and poor sleep. But prescriptions plunged worldwide in 2002 after an initial report from the Women\u2019s Health Initiative (WHI) \u2014 a long-term US study \u2014 suggested that postmenopausal participants who were taking oestrogen and progestin (a synthetic form of progesterone) had slightly increased risks of breast cancer, heart attack and stroke1<\/a>. The findings \u2014 widely misinterpreted and overgeneralized<\/a> \u2014 sparked fear among women and clinicians.<\/p>\n In January 2003, the FDA announced that oestrogen-containing menopausal hormone therapy products would require a \u2018black box\u2019 safety warning, the agency\u2019s strongest. Regulatory agencies around the world followed the FDA\u2019s lead by changing labels and issuing advisories. Use of these products remained low even though later research hinted at reduced risks of heart disease and death among hormone-therapy users, and lower rates of breast cancer among those taking oestrogen-only therapy.<\/p>\n
![\"\"](\"https:\/\/www.newsbeep.com\/il\/wp-content\/uploads\/2025\/11\/d41586-025-03687-0_25312650.jpg\"\/)
<\/p>\n