
"WASHINGTON -- 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."
"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. Many doctors - and pharmaceutical companies - have called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit."
FDA will remove the boxed warning from more than 20 hormone-containing pills, patches and creams used to treat menopause symptoms such as hot flashes and night sweats. Health officials cited studies indicating hormone therapy carries few serious risks when started before age 60 and within ten years of menopause onset. The existing 22-year-old boxed warning linked hormone therapy to blood clots, heart problems and other conditions based on an influential older study. Some medical leaders and pharmaceutical companies supported the change, arguing the warning discourages beneficial prescriptions, while other experts criticized the transparency and rigor of the decision process.
Read at ABC7 Los Angeles
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