‘Black box’ safety warning to be removed from hormone therapy for menopause

The US Food and Drug Administration will take steps to remove the "black box" safety warning from hormone therapy for menopause. Sarah Silbiger/Getty Images

In a pivotal move, the US Food and Drug Administration on Monday said it is taking steps to remove the lengthy “black box” warning on many hormone treatments for women with menopause symptoms — a shift expected to give women more options for treatment and generate a flood of new prescriptions.

Hormone therapy has long been on the market, but prescriptions plummeted after 2003, when the warning described increased risks of cardiovascular disease, stroke, breast cancer and dementia.

Prescribing requires nuance, FDA officials said Monday. Hormones should be used in women who are younger than age 60 or within 10 years of menopause.