"The U.S. Department of Health and Human Services announced today that the Food and Drug Administration will remove so-called black box labels from hormone replacement therapy (HRT) medications for menopause. The move reverses a decision that came down in the early 2000s, after research at the time found that the therapies increased the risk of breast cancer, heart disease and stroke in some women."
"A black box warning is the most severe notification of safety issues on a medication and is typically applied to an entire class of treatments based on how they work in the body. The FDA's commissioner Marty Makary called the use of black box warning labels for HRT for menopause unscientific in a press conference about the announcement. Experts say the FDA's decision might make hormonal therapies more accessible to people with menopausal symptoms, which include hot flashes and night sweats."
The FDA will remove black box warnings from hormone replacement therapies for menopause, reversing an early-2000s decision that linked HRT to higher risks of breast cancer, heart disease and stroke. A black box warning signals the most severe safety concern and is often applied to a whole treatment class based on mechanism of action. FDA commissioner Marty Makary described prior black box labels for menopausal HRT as unscientific. Experts say removing the warnings may increase access for people with hot flashes and night sweats, note that earlier risks were likely overstated, and caution that benefits for other conditions may also have been exaggerated. The Women's Health Initiative has conducted long-term studies since 1991 on heart disease, cancer and osteoporosis in postmenopausal women with primary NIH funding.
Read at www.scientificamerican.com
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