 
The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After more than two decades of fear and misinformation surrounding hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from HRT products for menopause.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. made the announcement at a press conference at HHS with more than 200 people in attendance, including Second Lady of the United States Usha Vance and Secretary of Labor Lori Chavez-DeRemer.
Women have used HRT products for decades to relieve menopausal symptoms. However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistically non-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.
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel 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.
Additional Resources:
FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
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