On November 10, 2025, the Department of Health and Human Services announced that the Food and Drug Administration will begin to remove the “black box” warning language related to increased risks of cardiovascular disease, breast cancer, and probable dementia from hormone replacement therapy (HRT) products for menopause. The decision was based on a comprehensive review of the scientific data and expert panel consensus.
In response to the change and its potential implications in cancer care, ASCO issued the following statement:
“For many women without a history of cancer, this FDA change is intended to reduce fear and align with current data. For healthy women, particularly those under age 60 or within 10 years of menopause onset, the benefits of using systemic HRT for menopausal symptoms can outweigh the risks.
“ASCO cautions, however, that this labeling change does not apply to individuals with a history of estrogen-responsive cancers.
“Systemic hormone replacement therapy remains contraindicated for people who previously had breast cancer, particularly those with hormone receptor-positive disease, or other estrogen-responsive cancers (for example, certain gynecologic cancers), due to an increased risk of cancer recurrence. Low-dose vaginal estrogen remains a good option for breast cancer survivors whose genitourinary symptoms do not respond to non-hormonal treatments such as vaginal lubricants and moisturizers, after discussing the relative risks and benefits with their oncology professional.”
