"The "black box" warning labels were based on what many experts now consider flawed research on HRT from more than 20 years ago. Part of the criticism is that back in 2002, researchers on the Women's Health Initiative study overstated the risks of breast cancer because the data focused on older women. More recent studies have shown the benefits outweigh the risk for many women if hormone therapy is used in the early years of menopause, before the age of 60."
"With the exception of vaccines or antibiotics, there's no medication that can improve the health of women on a population level more than hormone replacement therapy," Makary told senior correspondent Norah O'Donnell, explaining that studies show that menopause hormone therapy can reduce the risk of heart attacks, the leading cause of death in women. "We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits," Makary said."
"FDA Commissioner Dr. Marty Makary said in an exclusive CBS News interview that the change ends a decades-long "fear machine," and he called the demonization of menopause hormone therapy, also known as hormone replacement therapy (HRT), "an American tragedy.""
The FDA will remove "black box" warning labels on many hormone therapy drugs used for menopause and perimenopause. The change responds to updated evidence showing earlier research overstated risks because it focused on older women. Studies indicate that when used in early menopause, before age 60, hormone therapy can reduce heart attack risk and may lower risks of cognitive decline, Alzheimer's, and osteoporosis-related fractures. Hormone therapy also relieves debilitating menopause symptoms such as hot flashes, insomnia, night sweats, mood swings, joint pain, and weight gain. The label change is intended to reduce fear and encourage appropriate treatment for eligible women.
Read at Cbsnews
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