FDA Reverses Decades-Old Warning on Hormone Therapy Products for Menopause
FDA ends decades-old warnings based on outdated studies, citing benefits like reduced heart disease and osteoporosis risk for menopausal women, boosting treatment access.
- The FDA announced it will remove the "black box" warning labels from hormone replacement therapy products, claiming earlier fears about their safety were not supported by research.
- Commissioner Dr. Marty Makary stated that earlier warnings about hormone replacement therapy linked to breast cancer were based on misrepresented data and created unnecessary fears.
- Health Secretary Robert F. Kennedy Jr. emphasized that the decision reflects a need for evidence-based medicine and aims to empower patients.
151 Articles
151 Articles
FDA removes long-standing warning from hormone-based menopause drugs
By Matthew Perrone | Associated Press WASHINGTON — Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration announced Monday. U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are app…
FDA removes warning label from hormone-based menopause drugs, sidestepping usual process
Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia, and other serious risks, the Food and Drug Administration announced Monday. U.S. health officials said they will remove the boxed warning from more than 20 pills, patches, and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night swea…
FDA to remove black box warning from hormone replacement therapy drugs • Maine Morning Star
Blister packs of hormone replacement therapy medication. (Getty photos)WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed. The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative s…
FDA to remove black box warning from hormone replacement therapy drugs
Blister packs of hormone replacement therapy medication. (Getty photos)WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed. The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative s…
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