FDA removes warning label from hormone-based menopause drugs, sidestepping usual process

"Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia, and other serious risks, the Food and Drug Administration announced Monday. U.S. health officials said they will remove the boxed warning from more than 20 pills, patches, and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats."

"Health officials explained the move by pointing to studies suggesting hormone therapy has few risks when started before age 60 and within 10 years of menopause symptoms. "We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts," Health Secretary Robert F. Kennedy Jr. said in introducing the update. The 22-year-old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems, and other health issues, citing data from an influential study published more than 20 years ago."

The FDA will remove the boxed warning from more than 20 hormone-based pills, patches, and creams used to treat menopause symptoms such as hot flashes and night sweats. Health officials cited studies indicating hormone therapy has few risks when started before age 60 and within 10 years of menopause onset. Supporters, including some physicians and the FDA commissioner, say the label discouraged beneficial treatment. Opponents argue the decision-making process lacked sufficient transparency and that independent advisers should have been convened for public review. The previous warning referenced data from a study published more than two decades ago.

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