11/14/2025
Estrogen, Progesterone, and testosterone are essential for the health and wellbeing for all women. Menopause destroys you! The FDA is removing the black box warning about cardiovascular disease, breast cancer, and dementia from most estrogen hormone therapy products used for menopausal symptoms. This change follows an updated assessment of scientific evidence, particularly concerning younger cohorts starting therapy shortly after menopause onset, and aims to improve a patient’s ability to make informed decisions with their healthcare providers. The warning for endometrial cancer on estrogen-only products for women with a uterus remains.
Reasoning: The FDA’s decision is based on a re-evaluation of current scientific literature, which suggests the original warnings were based on data from older women and may not apply to women who start hormone therapy within 10 years of menopause or before age 60.
Impact on patients: The updated labeling is intended to provide a more nuanced and accurate risk-benefit assessment, encouraging shared decision-making between patients and their doctors. The American College of Obstetricians and Gynecologists (ACOG) supports the change, noting that the previous warning was a barrier for patients needing relief from menopausal symptoms, especially with low-dose vaginal estrogen.
Updated guidance: While the specific timing and duration of therapy remain a decision for the patient and prescriber, the FDA’s labeled recommendation will now be to start systemic hormone therapy within 10 years of menopause or before 60 years of age.
