FDA Removes Black Box Warning on Hormone Therapy

U.S. health officials have announced the first steps to remove the black box warning on estrogen products prescribed to treat symptoms of menopause.

The warning was added to the products in 2003 when data from a large government study on women’s health, known as the Women’s Health initiative (WHI), showed that the hormone therapy was linked to an increased risk of a number of conditions, including breast cancer, heart disease, blood clots, and potentially dementia.

Women’s health experts say the risks were misinterpreted, and did not properly reflect the data from the study. The result—in the following years, many women, and the doctors caring for them, avoided hormone therapy to treat menopause symptoms such as hot flashes, night sweats and mood changes.

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