The U.S. Food and Drug Administration will begin removing broad “black box” warnings from hormone replacement therapy products for menopause, the Department of Health and Human Services announced.
HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H., made the announcement at a recent press conference.
Women have used HRT products for decades to relieve menopausal symptoms, but their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistical but not significant increase in the risk of breast cancer diagnosis. The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use, according to a press release from the FDA.
The FDA is initiating the removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel meeting in July and a public comment period. The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone 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.”
In addition to the removal of boxed warnings, the FDA is also approving two new drugs to expand treatment options for menopausal symptoms. The first is the approval of a generic version of Premarin (conjugated estrogens), the first such approval in more than 30 years for this widely used hormone replacement therapy. The new generic product is expected to improve affordability and access while maintaining the same quality, safety and effectiveness as the brand-name drug.
The second approval is for a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause. This option provides relief for women who cannot or choose not to use hormone therapy.
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