RFK Jr announces removal of ‘black box’ warnings on key medications for women
Health and Human Services Secretary Robert F. Kennedy Jr. announced Monday that the FDA will remove the severe warnings from hormone replacement therapy drugs used in the treatment of menopause for women
by Summer Lane | November 10, 2025
On Monday, the U.S. Department of Health and Human Services announced that, in conjunction with the U.S. Food and Drug Administration (FDA), it would begin removing “black box” warnings from hormone replacement therapy drugs for the treatment of women in menopause.
According to a press release from the FDA, the announcement was made by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Mark Makary during a press conference.
“For more than two decades, the American medical establishment turned it back on women,” Kennedy said. “Millions of women were told to fear the very therapy that could have given them strength, peace, and dignity through one of life’s most difficult transitions — menopause. That ends today.”
What is a “black box” warning? It is a strict prescription drug warning issued by the FDA, also known as a “Boxed Warning.”
According to Drugs.com, it alerts healthcare providers and patients to potential life-threatening adverse reactions linked to the drug, as well as possible side effects.
Per the FDA, the HRT warnings will be removed after a “comprehensive review of the scientific literature, an expert panel in July, and a public comment period.”
FDA Commissioner Makary noted in his remarks on Monday, “Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk…Women and their physicians should make decisions based on data, not fear.”
HRT therapies can contain both estrogen and progesterone, or singularly, estrogen, to treat declining hormones in menopausal or postmenopausal women, the FDA said. According to the agency’s data:
“Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Women may also reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%.”
The agency is also approving two new drugs for the treatment of menopause: a generic version of Premarin and a second, yet unnamed drug.
