The recent removal of the “black box” warning from FDA-approved prescription hormone therapy marks an important moment in women’s health— and one that has been met with both excitement and caution in medical circles.
Keep reading to hear from Bonafide Chief Medical Officer, Dr. Alyssa Dweck, who breaks down what this update means, why it matters, and how it may help reduce longstanding confusion around the safety of hormone therapy.
Some important news has come from the FDA regarding women's health and hormone therapy.
On November 10th, the FDA announced it is removing the black box warning, the strongest warning the FDA places on drugs, and updating the label for both local vaginal and systemic hormone therapy.
For local vaginal estrogen, the label will no longer reference the higher risk of cardiovascular disease, breast cancer, endometrial cancer, and probable dementia.
Vaginal estrogen use is widely accepted as safe and effective for most, if not all women with genitourinary syndrome of menopause (GSM) symptoms, and this announcement was received as definitively positive in the medical world with very little, to no downside.
The FDA is also removing references to risk of cardiovascular disease, breast cancer and probable dementia on all systemic estrogen containing hormone therapy products. This applies to single ingredient (estrogen only), and combination estrogen / progestogen products. The black box warning for risk of endometrial cancer will remain for estrogen alone products.
This announcement was met with mixed feelings by the medical community since there are nuances in symptom management that are based on personal medical history, route of administration, age of initiation, and dose and duration. Treatment must be based on specific provider and patient shared decision making.
The labeling on systemic estrogen containing hormone therapy products will also be updated to reflect that studies suggest hormone therapy is best initiated within 10 years of the onset of menopause and before age 60.
The removal of the boxed warning from local estrogen therapies is not only a major win for women’s health—it’s genuinely breaking news in a field where progress often moves slowly. While the packaging update is still being rolled out across product labels, the significance of this change is clear. It reflects years of scientific evidence supporting the safety of low-dose, localized estrogen and helps correct long-standing misconceptions that may have discouraged women from exploring treatment options that could potentially restore their quality of life.
