On November 10, the Food and Drug Administration (FDA) announced that hormone therapies for the treatment of menopause will no longer feature the black box warning about the risk of breast cancer, heart attack, and stroke. A “generic mixture of estrogen hormones and a nonhormonal treatment for moderate to severe hot flashes” were approved by the FDA on the same day. Furthermore, systemic hormone therapies will be recommended by the agency.
Singing the praises of hormone replacement therapy, FDA Commissioner Marty Makary, along with other officials, wrote an editorial for The Journal of the American Medical Association (JAMA).
“We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” Makary said in a news conference. “The FDA is taking action to remove the black box warnings from estrogen-related products. This is based on a robust review of the latest scientific evidence.”
NBC
This is despite hormone replacement therapy not being a panacea. It does not increase longevity. Age, the type of hormone therapy, and pre-existing conditions may render treatment riskier for some patients.
Health and Human Services Secretary Robert F. Kennedy (RFK) Jr. and Makary exaggerated the ability of hormone therapy to reduce the risks of Alzheimer’s and cardiovascular disease. Menopause researcher Dr. Nanette Santoro found that the two cherry-picked data that supported such a claim. The two “also downplayed risks of systemic” menopausal hormone therapy (MHT), which may result in breast cancer.
