FDA Removes Boxed Warning from Menopause Hormone Drugs

The Food and Drug Administration announced Monday that it will remove the boxed warning from more than 20 hormone-based medications used to treat menopause symptoms such as hot flashes and night sweats. The drugs, which include pills, patches and creams containing estrogen and progestin, have carried the prominent label since 2002, highlighting risks including stroke, heart attack, blood clots, breast cancer and dementia.

The decision, outlined in updated prescribing information, reflects evolving research on the therapies' risks and benefits. FDA officials, including Commissioner Marty Makary, stated that studies indicate hormone therapy poses few serious risks when initiated before age 60 or within 10 years of menopause onset. The original warning stemmed from the Women's Health Initiative, a landmark 2002 study involving over 26,000 women that linked certain hormone pills to elevated health dangers, particularly in older participants. That research prompted a sharp decline in prescriptions across all age groups, and national data shows usage has remained low over the past two decades.

In a commentary published Monday in the Journal of the American Medical Association, Makary...