The Food and Drug Administration (FDA) announced that it will remove the “black box” warning from Hormone Replacement Therapy (HRT) products prescribed for menopause, reversing decades-old cautions about serious health risks. The warning had highlighted potential dangers such as breast cancer, heart attack, and stroke, discouraging many women from seeking treatment.
FDA Commissioner Marty Makary explained that the change reflects updated scientific evidence. “We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” he remarked. The updated guidance applies to medications containing estrogen, progestogen, or both.
HRT is commonly prescribed to alleviate menopause symptoms, including hot flashes, mood swings, sleep disturbances, urinary tract infections, bone fractures, and vaginal dryness. The medications replace hormones that naturally decline during menopause and are available as pills, patches, gels, or creams.
The original black box warnings stemmed from a 2002 clinical trial that linked HRT to increased risks of breast cancer, heart attack, and stroke. That study focused on a specific progesterone formulation rarely used today and largely included women in their 60s and 70s, whereas hormone therapy typically started in the 40s or 50s. Prescriptions for HRT declined sharply following the trial.
Current evidence indicates that starting HRT before age 60 or within ten years of menopause onset carries benefits that outweigh risks. The FDA said medication labels will be updated accordingly, though package inserts will continue to note potential adverse events.
Health and Human Services Secretary Robert F. Kennedy Jr. noted it followed “a thorough, evidence-based review of decades of scientific data, an expert panel and public testimony.”
For some women, the update offers renewed hope. Beaux Abington, 51, who struggled to obtain HRT, observed significant improvements after starting treatment, commenting, “It just was like all of the parts of my brain coming alive again.”
