The US Food and Drug Administration is considering removing the black box warning on hormone therapy treatments that contain estrogen, citing new evidence that suggests these treatments may not increase the risk of strokes, blood clots, dementia, and breast cancer.
According to Dr. Leana Wen, an emergency physician and adjunct associate professor at George Washington University, menopause is a natural stage in a woman’s life when menstrual periods permanently stop. Symptoms associated with menopause can include hot flashes, night sweats, vaginal dryness, decreased libido, and mood changes. Hormone therapies are prescription drugs that replace the hormones that decline during menopause.
There are two types of hormone therapy: systemic therapy, which is used to treat symptoms that affect the entire body, and low-dose vaginal estrogen therapy, which is administered into the vagina to treat vaginal dryness and reduce tissue thinning. The black box warning was added in 2003 after a landmark study suggested that hormone therapy increased the risk of breast cancer, heart disease, and stroke.
However, some researchers have re-examined the methodological problems of the original study and found that hormone treatment with a combination of estrogen and progesterone is safe and effective for treating hot flashes and other systemic symptoms if started before age 60 or within 10 years of starting menopause. This updated analysis has led to calls to remove the black box warning, arguing that it misrepresents risk and makes it harder for women to receive relief from troublesome symptoms.
Despite the potential removal of the warning, there are still arguments against removing it. Some experts argue that hormone therapy should not be taken for preventive purposes, and that a more balanced approach is needed to consider the views of both pro-hormone therapy advocates and those with nuanced views.
For women experiencing significant menopause symptoms, Dr. Wen advises speaking with their physicians about lifestyle measures, hormonal, and nonhormonal prescription therapies, as well as preventive care to improve heart health and prevent bone loss. Women can also seek additional resources from the Menopause Society, which has a searchable database of clinicians certified in menopause practitioners.
Source: https://edition.cnn.com/2025/07/24/health/menopause-hormone-treatment-wellness