“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” the health secretary said.
Federal officials are removing a warning from treatments for menopause symptoms, they announced on Nov. 10.
Hormone replacement therapy, or estrogen treatments, will no longer warn women that taking the treatments can raise the risk of cardiovascular disease, breast cancer, and probable dementia, the Department of Health and Human Services (HHS), the parent agency of the Food and Drug Administration, said in a statement.
The FDA will work with companies that make the drugs to update language on labels for the products.
“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said at a press conference in Washington announcing the move. “When prescribed responsibly and started early, hormone replacement therapy transforms the lives of women.”
Menopause, which refers to when a woman’s menstrual period ends, usually starts with a transitional phase called perimenopause when a woman is in her mid-40s. The process of menopause lasts a number of years and can include symptoms such as problems sleeping and hot flashes.
Before the FDA marked hormone replacement therapy with the warning in the early 2000s, about one in four women took the treatments, Kennedy said. That figure is currently fewer than one in 20.
Experts convened by the FDA over the summer advised the FDA to remove the black box warning, which they said caused some women not to use treatments that can alleviate menopause symptoms such as vaginal dryness.
“There’s not a single study in the literature that says local vaginal estrogen causes stroke, blood clots, heart attacks, breast cancer, or probable dementia, which is what your box says,” Dr. Rachel Rubin, a urologist, said at the time.
The warning is based on a study released in 2002 called the Women’s Health Initiative, which found an increase in the risk of breast cancer among recipients of the estrogen drugs. But the increase was not statistically significant, and the product analyzed is no longer in use, HHS said.
“If we don’t have statistics, we don’t have science,” Dr. Marty Makary, commissioner of the FDA, told the briefing on Nov. 10.
