The Food and Drug Administration has removed its long-standing “black box” warning from hormone-based menopause drugs. The label, which had cautioned about stroke, heart attack, and dementia risks, is being dropped after new evidence showed the treatments are much safer for many women. The change affects more than 20 estrogen and progestin products, including pills, patches, and creams used to ease hot flashes and other menopause symptoms.
Officials say studies now show that hormone therapy carries little risk when started before age 60 or within 10 years of menopause. The warning, first issued in 2002, came from an early study that linked hormone therapy to heart disease, blood clots, and cancer — leading to a sharp decline in prescriptions.
But newer research shows younger women face far fewer cardiovascular risks, while older women, especially those in their 70s, may still need to be cautious. Newer, low-dose products such as vaginal creams are also considered safer than older hormone drugs.
Experts are divided on the FDA’s move. Some say removing the warning will help women and doctors make more personalized, confident decisions about treatment. Others have criticized the agency for not consulting its independent advisory panel first. Still, most agree that hormone therapy can be safe and effective when tailored to each woman’s health history and needs.
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