AARP

By Paul Goldfinger, MD, FACC.  Blogfinger.net.

From “Total News” and the AMA:

“The Secretary of Health and Human Services, Robert F. Kennedy Jr., declared on Nov. 10, 2025, that the black box warnings associated with estrogen-based hormone replacement therapy (HRT) for women will be eliminated.

“For over two decades, American medical institutions have turned their backs on women,” Kennedy stated during a press conference at HHS headquarters. He expressed that millions have been made to fear a therapy that could provide them strength and dignity during challenging stages like menopause.

“It may also reduce the outsized fear that has prevented approximately 50 million women from the short- and long-term health benefits of this therapy. If implemented, these changes may guide appropriately tailored hormone therapy use and optimize individualized care.

“Hormone replacement therapy for women undergoing menopause will no longer carry warnings about significant health risks, the Food and Drug Administration said yesterday.

“The medications contain estrogen and progesterone, two hormones involved in bone density and brain health. As a woman’s egg supply diminishes, her levels decline until she no longer produces them. The process takes seven to 10 years on average and can be accompanied by symptoms including hot flashes, insomnia, brain fog, and an increased risk of fractures.

“After decades of use the FDA presented data that showed 30 percent of women forgo HRT due to the intimidating black box label.   That changes today, they  insisted, announcing that the FDA will start to lift the extensive warnings related to HRT products aimed at easing menopausal symptoms.”

This is from JAMA.  (Journal of the AMA):

Current evidence suggests that hormone therapy initiated within a decade of the onset of perimenopause has been associated with numerous long-term health benefits, including reduced vasomotor symptoms, without significantly affecting atherosclerotic cardiovascular disease among younger postmenopausal women aged 50 to 59 years.  

Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events (the leading cause of death in women), a 50% to 60% reduction in bone fractures,³ a 64% reduction in cognitive decline,⁴ and a 35% decreased risk of Alzheimer disease.⁵   

With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy. In addition, hormone therapy is FDA approved to treat moderate to severe menopausal symptoms, such as hot flashes, night sweats that could lead to debilitating sleep disruption, and mood changes.

Following the release of findings from the 2002 Women’s Health Initiative (WHI), hormone therapy prescriptions decreased due to fears that hormone therapy increased a woman’s risk of dying of breast cancer. The increased risk in breast cancer cases observed in the original WHI study (1 additional nonfatal breast cancer diagnosis per 1000 women treated in a year) has been subsequently recognized to be attributed to the particular progesterone formulation used in the study, medroxyprogesterone acetate—a formulation that is not in common use today for hormone therapy.

The WHI trials in 2002 (estrogen-progestin trial) and 2004 (estrogen-only trial) evaluated the benefits and risks of 1 type and dose of estrogen and progestin for prevention of cardiovascular disease and other chronic medical conditions in postmenopausal women aged 50 to 79 years. 

Blogfinger comment:  During the years when HRT  (hormone replacement therapy) was recommended, as a cardiologist I insisted that all my menopausal patients go on HRT.   If their gyn. failed to recommend it, I gave it myself.

I was enthused, but then I was shocked when we were later advised to reverse that idea because of an increased risk of breast cancer.

But now, WOW, the announcement above changes all that again, taking us back to the original plan.  Adding estrogens back provides  additional benefits besides cardiovascular. which have been lost in recent years:  less depression, better vaginal  lubrication, less urine infections and other benefits  including less hot flushes, mood swings, sleep problems, trouble concentrating and night sweats.

This is not my field, so I encourage BF readers to be alert to all the details which will be presented soon by the FDA and other professional groups such as the AMA,  and especially by conversations which you should have with your gynecologist.  Pay attention to warnings: side effects and risks of treatment.

For now I am thrilled to tell you about this discovery, so that you can find out if you will qualify.  The exact formulations which patients will be advised to take have not been announced yet!

And don’t fall for any of those phony Internet claims for “natural” remedies.  Listen to your doctor and avoid  fake physicians on line or elsewhere including quack chiropractors and over-zealous  nurse/physician assistants.

If your doctor won’t talk to you or call you back, find one who will.

IRENE BYATT.   “South Pacific”