FDA to remove ‘black box’ warning from menopause hormone therapy

(NewsNation) — Health Secretary Robert F. Kennedy Jr. announced Monday that the U.S. Food and Drug Administration will begin removing the long-standing “black box” warnings for hormone therapy replacement (HRT) products to treat menopause symptoms.

“The era of ignoring women’s health is over,” Kennedy said. “We’re challenging outdated thinking and recommitting to evidence-based medicine.”

According to the Department of Health and Human Services, HRT has been used for decades to relieve symptoms such as hot flashes, night sweats and bone loss. However, its use dropped sharply in the early 2000s after the FDA added boxed warnings citing a possible link to breast cancer, based on data from the Women’s Health Initiative study. The study included women with an average age of 63, over the typical onset of menopause, and used a hormone formulation that is no longer in common use.

Following a comprehensive review, an expert panel meeting in July, and a public comment period, the FDA is now moving to remove those warnings. Updated product labeling will no longer include reference to elevated “risks of cardiovascular disease, breast cancer, and probable dementia.” However, the agency will retain the boxed warning for endometrial cancer in estrogen-only products.

“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,” Kennedy said. “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.”

FDA Commissioner Makary echoed that message, staying, “Tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk.”

Alongside the label changes, the FDA also announced two new approvals to expand treatment options:

• A generic version of Premarin (conjugated estrogens), the first in more than 30 years, aimed at improving affordability and access.
• A non-hormonal medication for moderate to sever hot flashes and other vasomotor symptoms, offering an alternative for women who cannon or prefer not ot ruse hormone therapy.