(NewsNation) — Health Secretary Robert F. Kennedy Jr. announced Monday that the Food and Drug Administration will begin removing the long-standing “black box” warnings for drugs used to treat menopause.
“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 “We’re challenging outdated thinking and recommitting to evidence-based medicine.”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, hormone replacement therapy 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 warnings citing a possible link to breast cancer, based on data from a 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 references 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 Marty Makary echoed that message, saying, “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 nonhormonal medication for moderate to severe hot flashes and other vasomotor symptoms, offering an alternative for women who cannot or prefer not to use hormone therapy.
Hormone therapy black box warning was ‘greatest screwup’: FDA commissioner
Makary told NewsNation the black box warnings were “one of the greatest screwups in the last 25 years of modern medicine.”
The landmark decision affects approximately 75 million American women experiencing menopause. The FDA is now encouraging women to consider hormone replacement therapy to alleviate symptoms including insomnia, anxiety, brain fog, depression and osteoporosis.
Makary said studies show the therapies can reduce heart disease risk by 50%, bone fractures by 50%, cognitive decline, including Alzheimer’s, by 60% and urinary tract infections by 50%.
“There may be no medication that improves the health outcomes of women at a population level more than hormone replacement therapy initiated within 10 years of the onset of menopause,” Makary told NewsNation.
The 2002 study linking HRT to breast cancer led to the original black box warning. The narrow, incomplete study caused hormone therapy use to plummet from 40% to 5% within months as women abandoned their medications.
Makary said the study lacked statistical significance regarding increased breast cancer risk. Women taking estrogen alone showed a 24% reduction in breast cancer, and no trial has shown HRT increases breast cancer mortality, he said.
The commissioner criticized what he called a “male-dominated, historic profession that engaged in a paternalistic approach” to women’s health issues.
Heart attacks remain the leading cause of death in women. An average woman who reaches age 80 faces a 1 in 3 chance of hip fracture, which carries a 22% one-year mortality rate.
Approximately 2 million American women enter menopause annually.