The U.S. Food and Drug Administration (FDA) will remove the strongest warning, called a “black box,” from many hormone therapies used to treat menopause symptoms. The warning has been on these medicines since 2003 and warned of risks like heart attacks, strokes, blood clots, dementia, and some cancers.
FDA officials say new research shows that hormone therapy can be safe if started at the right time usually within 10 years of the start of menopause or before age 60. The agency hopes this change will help women and doctors feel more confident in using these treatments.
The black box warning has made many women and doctors avoid hormone therapy, even when menopause symptoms were severe, like hot flashes, night sweats, and vaginal dryness.
Experts say the old warning gave a general message that did not match the latest research. The risks depend on age, health, timing, and type of hormone therapy.
With the new rules, drug companies will update labels for pills, patches, creams, and other hormone products. Some warnings will remain, such as the risk of uterine cancer for women who take estrogen alone and still have a uterus.
Doctors and supporters say this change will allow more personalized treatment. Women can now discuss the right dose and timing with their doctor, weighing benefits like symptom relief, stronger bones, and better quality of life against possible risks.
Some experts are cautious and want more studies to confirm safety. They say patients should still talk to their doctors about their personal health risks before starting hormone therapy.
The FDA emphasizes that using hormone therapy is a personal choice. Removing the black box warning does not mean the therapy is completely risk-free, but it may help more women get safe treatment and live better during menopause.
