FDA ‘liberates’ hormone therapy for menopause

FDA ‘liberates’ hormone therapy for menopause


Food and Drug Administration Commissioner Marty Makary announced on Monday that his agency is deregulating hormone replacement therapies for menopause patients by calling for manufacturers to remove black box warnings from their products.

Black box warnings are the highest level of caution that the FDA requires for certain potentially dangerous products. Makary, in an opinion piece in the Wall Street Journal on Monday, cited several studies touting the benefits of hormone replacement therapy and demonstrating a lack of correlation between HRT and dangerous outcomes such as breast cancer.

“These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment,” Makary wrote.

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HRT for menopause consists of estrogen and progesterone, or solely estrogen for

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