The Food and Drug Administration (FDA) announced it will remove the strictest black box warning labels for hormone replacement therapy (HRT) products used to treat menopause symptoms. Black box warnings highlight serious risks such as major injury or death; those warnings have been on HRT products for more than two decades and, the agency says, have caused fear and confusion around hormone therapy.
HHS Secretary Robert F. Kennedy Jr. said outdated science and bureaucratic inertia have left women and clinicians with an incomplete view of HRT, and that the change returns decision-making to evidence-based medicine. FDA Commissioner Marty Makary, MD, MPH, said millions of women have been denied potential benefits of HRT because of “distorted” risk messages on labels.
The FDA is asking HRT manufacturers to update wording related to risks of cardiovascular disease, breast cancer, and dementia. The agency is not seeking removal of warnings about endometrial cancer from systemic estrogen-alone products. The decision follows an FDA review of current literature and an expert panel reassessment, including reanalysis of data from people who began HRT within 10 years of menopause onset.
Removing the black box warnings aims to address underutilization of HRT for menopausal symptom relief and to reduce stigma that can deter patients and clinicians from discussing or prescribing therapy. Experts say the change should increase clinician awareness, improve education across specialties, and expand access to individualized care for those experiencing menopause.
HRT was first approved for certain menopause symptoms in 1941. After the Women’s Health Initiative (WHI) studies in the 1990s suggested increased risks of cardiovascular events, breast cancer, and pulmonary embolism, HRT use fell sharply—about 45%—and the black box labels were applied. Some experts have called aspects of the WHI findings flawed or misapplied to all menopausal patients.
Clinicians note that HRT’s benefits—relief of hot flashes, night sweats, sleep problems, and other symptoms—are often greatest when therapy starts within the first 10 years after menopause begins. Starting HRT remains an individualized decision made between a patient and a qualified provider, weighing benefits and risks based on age, health history, and timing relative to menopause.
Supporters of the labeling change say it will foster more open, evidence-based patient–provider conversations and lead to increased referrals to menopause-focused care. While the FDA’s action does not erase all cautions—some risk language will remain and endometrial cancer warnings for certain estrogen-only products will stay—the shift signals a move toward more nuanced guidance that reflects current evidence and improves access to treatment options.
