What you need to know as FDA removes ‘black box’ warning on menopause hormone treatment

COLORADO SPRINGS, Colo. (KRDO) -- The United States Food and Drug Administration (FDA) has removed "black box" warnings on many hormone treatments used to treat menopause symptoms.

The warning is the strictest type of warning the FDA puts on drug labels.

"The warnings actually came in the early 2000's and they were largely in response to the Women's Health Initiative Study that raised concerns over increased risk of breast cancer, heart disease, blood clots, and even dementia," said KRDO13's medical expert, Dr. Neha Sharma. "But since then, the risk has been recalibrated because of newer evidence."

The decision to remove the warning comes as the use of the drugs to relieve menopause symptoms has plummeted, as women worried over the potential risk of breast cancer. Health and Human Services Secretary Robert F. Kennedy Jr. says that the risk concerns came from outdated studies.

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy in a press release. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”

Medical experts say evidence is currently showing that the benefits of hormone replacement therapy (HRT) outweigh the potential risks when taken before age 60-- or within 10 years of the onset of menopause.

"It was designed to help with menopausal symptoms for relief, and it also improves bone health. It prevents osteoporosis. It's good for heart disease. It can lower the risk of strokes," said Dr. Sharma.

However, the endometrial cancer warning will remain on the box for systemic estrogen-alone products.

"The risk of certain cancers like breast, ovarian, endometrial-- they still remain. The risk of blood clot is still there," said Dr. Sharma. "(But) because the warning is removed, the decision to start HRT is not going to be driven by fear anymore."

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