"On Monday, the FDA announced that hormone replacement therapy (HRT) products will no longer carry black box warnings stating they cause increased risk of breast cancer, heart attack, and stroke. The label was added to these products in the early 2000s following the publication of the Women's Health Initiative study, the results of which experts say were misinterpreted. The FDA's announcement states that the study "found a statistically nonsignificant increase in the risk of breast cancer diagnosis."
"Hormone replacement therapy is used to treat symptoms of perimenopause and menopause, including hot flashes, sexual and genitourinary symptoms, and even loss of bone density. Tens of millions of American women are currently in menopause, and two million more are added to that total annually. In an interview with CBS, urologist and menopause expert Dr. Rachel Rubin said that hormones are like the body's gas tank. When they fluctuate during perimenopause and halt in menopause, "every cell in your body will feel the consequences.""
The FDA has removed black-box warnings from hormone replacement therapy products that linked HRT to breast cancer, heart attack, and stroke. The original label traces to the early 2000s after the Women's Health Initiative study, which included older women and a hormone formulation no longer commonly used and whose results were later judged misinterpreted. The removal followed a comprehensive literature review, an expert panel, and public comment. HRT treats perimenopause and menopause symptoms such as hot flashes, sexual and genitourinary issues, and bone density loss. Menopause experts describe hormones as fundamental to bodily function and emphasize HRT’s safety and benefits.
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