For more than 20 years, women looking for relief from hot flashes, mood swings and other symptoms that often come with the 40s and 50s were told the remedy — hormone replacement therapy — had life-threatening side effects.
Now, though, just months after the Food and Drug Administration lifted that “black box warning” — the agency’s strongest safety alert — pharmacists nationwide are having a hard time keeping up with demand for the patches that deliver estrogen through the skin. That and other hormones are administered to mimic the hormones that stop being produced naturally as the end of female reproductive years approach.
Dr. Alexandra Lieberman, a Boca Raton board-certified obstetrician and gynecologist, sees hormone replacement therapy as part of an oncoming revolution in aging well, that’s still evolving. And it’s coming with benefits for women “from head to toe,” she said.
It makes sense that the sudden reduction in hormones that female bodies produce for decades would wreak havoc and cause all kinds of symptoms, like weakening bones, sleepless nights and wildly fluctuating body temperatures, Lieberman said. She’s heard about all the usual symptoms in addition to swollen joints, ringing in the ears and simply not feeling good anymore.
“Women were told for a long time that, ‘Well, you’re supposed to feel like this,’ or ‘It’s in your head,’” said Lieberman, also an adjunct professor at the Florida Atlantic University Charles E. Schmidt College of Medicine. “A lot of times, people were put on antidepressants at this point of their life rather than addressing that our hormones are decreasing.”
A 55-year-old Fort Myers woman said she searched for four months and visited numerous doctors before she got a prescription to replace her hormones that disappeared when she stopped getting her period in her early 50s. Two months on, she says it’s too early to tell how well it’s working except that, “I don’t feel like I’m going to keel over and die and I’m not wondering what’s wrong with me 24/7.”
The FDA warning that started in 2003 linked estrogen-containing products to breast cancer, heart disease, strokes, blood clots and dementia.
Ironically enough, Dr. Craig Tanio, an internal medicine doctor who runs a Hollywood practice focused on brain health and longevity, has seen hormone replacement therapy help some of his female patients with brain fog.
“Bioidentical hormones are one of the major interventions that can help cognition,” he said.
Here’s what to know about the change in mainstream medicine’s view of hormone replacement therapy, also known as HRT.
What are the signs you need hormone replacement therapy?
During perimenopause and menopause — usually when women hit their mid-40s — the ovaries stop producing high levels of estrogen and progesterone. The ovaries also reduce the production of other sex hormones, like testosterone. The reduction or cessation of these hormones means that body systems stop functioning like they have for decades, Lieberman said.
Some may experience symptoms that make life unbearable, ranging from zero interest in sex to weight gain to sleeplessness to thinning hair to heart palpitations.
“Our generation is definitely noticing more,” said Lieberman, recalling how the therapy was scarcely mentioned in her residency training.
Why did the FDA in 2003 issue a warning that replacing female hormones had life-threatening risks?
The warning was the result of the Women’s Health Initiative study results that have since been reevaluated, according to an FDA fact sheet. The FDA, in announcing the change in November 2025, found that the increase in breast cancer the study found shouldn’t have resulted in the warning.
The average age of women in the study was 63 years — more than a decade past the average age of a woman experiencing menopause, according to an FDA news release. Also, study participants were given a hormone formulation no longer in common use, according to the FDA.
The new intelligence from the FDA follows the 2021 change in advice on hormone replacement from the American College of Obstetricians and Gynecologists, Lieberman said.
Now, randomized studies show that women who initiate HRT within 10 years of the onset of menopause show fewer deaths 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%, according to the FDA report.
Who should take HRT?
The FDA’s new advice recommends that patients who start taking HRT for menopause and perimenopause symptom relief should be younger than 60 and within 10 years of their last period.
The therapy is not recommended for all women, Lieberman said. And insurance sometimes won’t cover other hormones that have given women relief.
“It’s a personal choice, because there are still risks,” Lieberman said. “Certain people can’t take it. If you have a history of blood clots, there’s mixed reviews. And if you have a personal history of breast cancer …”
Anne Geggis is statewide reporter for the USA TODAY NETWORK FLORIDA, reporting on health and senior issues. If you have news tips, please send them to ageggis@usatodayco.com. You can get all of Florida’s best content directly in your inbox each weekday by signing up for the free newsletter, Florida TODAY, at https://palmbeachpost.com/newsletters
This article originally appeared on Palm Beach Post: Hormone replacement therapy, once warned against, is making a comeback
Reporting by Anne Geggis, USA TODAY NETWORK – Florida / Palm Beach Post
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