Advisory Board November 12, 2025

FDA on Monday announced plans to remove “black box” warning labels from all hormone replacement treatments that contain estrogen and are used to treat symptoms of menopause and perimenopause — a decision that could encourage more people to seek treatment.

The potential risks of hormone therapy

Hormone therapy has been used to treat menopause symptoms since the 1940s, and by the 1980s, hormones were also being prescribed to prevent cardiovascular disease and osteoporosis, including in women past menopause age.

In the early 2000s, researchers conducted a large-scale study called the Women’s Health Initiative (WHI) to test whether estrogen or progesterone could help prevent chronic diseases in women with and without heart disease. However, the trials were stopped after researchers found...

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