Explained: FDA removes warning label from hormone treatments for menopause; what happens now (risk factors and safe practice tips)

In a major shift for women’s health, the Food and Drug Administration (FDA) has announced it will remove the prominent “black box” warning from many hormone therapies used to treat menopause symptoms. These therapies, typically involving estrogen, sometimes paired with progestin, have long carried the strongest caution label, warning of risks such as heart attack, stroke, and dementia. But new research shows that when used by women under age 60 or within ten years of menopause, the risks appear substantially lower. This regulatory update, although it opens the door to broader access to hormone therapy, raises questions about safe use, risk factors, and best-practice tips for women navigating menopause. Since around 2003, hormone therapy products (often called HRT or MHT — menopausal