FDA Approves HRT Label Changes

The agency cited updated evidence in revising hormone therapy safety language.

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The FDA has approved labeling changes for six menopausal hormone therapy products, removing specific risk statements from the boxed warning.
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The updated labeling reflects a comprehensive review of scientific literature regarding menopausal hormone therapies.
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Approved products include systemic combination therapy, systemic estrogen-alone therapy, and topical vaginal estrogen therapy.
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Hormone therapy can significantly improve quality of life by alleviating symptoms like hot flashes and preventing bone loss.
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Despite potential benefits, hormone therapy usage remains low, with only about 2 million women receiving prescriptions in 2020.

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