
"Women should not suffer through menopause with hot flashes, night sweats and poor sleep. That's the message from FDA Commissioner Dr. Marty Makary. The agency announced it will remove "black box" warning labels from estrogen-based hormone therapy, which treat the symptoms of menopause, saying the warnings have made women scared to try the therapy and doctors reluctant to prescribe it."
"The warnings stem from the early 2000s when data from the Women's Health Initiative study found hormone therapy increased risks of heart attacks, strokes, blood clots and breast cancer. But, women in that study were given a type of hormone therapy formulation that is no longer commonly used. And the average age of women in the study was 63, which is now considered too late to start hormone therapy."
""If you're under age 60 or within ten years of menopause onset, when you start hormone therapy, you're going to see improvements in hot flashes, sweats, fewer sleep disruptions, " says Dr. JoAnn Pinkerton, a menopause expert at the University of Virginia Health. She also points to protection against bone loss and fractures, as well as potential benefits for heart health, brain fog and overall quality of life."
FDA plans to remove the 'black box' warning from estrogen-based hormone therapy for menopause. Early 2000s Women's Health Initiative linked hormone therapy to heart attacks, strokes, blood clots, and breast cancer, but the study used a formulation rarely used now and enrolled older women (average age 63). Current evidence shows safer, effective formulations and benefits when started under age 60 or within ten years of menopause onset, including reductions in hot flashes, night sweats, sleep disruptions, protection against bone loss and fractures, and potential heart and cognitive benefits. Not all women can use hormone therapy; individualized risk assessment with a knowledgeable healthcare provider is essential.
Read at www.npr.org
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