Garrison: Hormone therapy isn’t so risky after all. I tried it and it changed my life.

The FDA’s decision to remove the “black box warning” on hormone replacement therapy is welcome news for menopausal women who had been scared off from it.

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The Minnesota Star Tribune
November 21, 2025 at 11:00AM
"Earlier this month, the Food and Drug Administration announced it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments that are prescribed to ease the symptoms of menopause and perimenopause. Why? Because several subsequent studies have found the risks identified in the 2002 study were misrepresented," Nicole Garrison writes. (Getty Images)

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It’s been a little over a year since I went on hormone replacement therapy (HRT) and I can say without hesitation, it’s one of the best things I’ve ever done for myself.

The relief wasn’t immediate. It took several months and some adjustments of my dose for my body to respond. But after a while, I noticed my energy returning and my sleep starting to improve. Even better, I could once again complete a coherent sentence and wasn’t so inexplicably angry that I was biting people’s heads off simply for breathing too loud.

But saying yes to HRT wasn’t easy.

A 2002 study by the Women’s Health Initiative suggested that HRT increases the risk of breast cancer and stroke. That study ultimately led to hormones carrying a “black box warning” detailing those risks, effectively deterring an entire generation of menopausal women from getting the treatment they deserved.

The reported risks certainly gave me pause, too.

“When we put a black box label on a drug, it kind of shuts down the conversation for a lot of women,” said Krista Margolis, a nurse practitioner who focuses in perimenopause/menopause care at Premier Women’s Health of Minnesota’s clinic in Edina. “As a society and as women, when you hear ‘breast cancer,’ it’s scary.”

In my case, there is no family history of breast cancer, though my father died of a heart attack at age 44 and my mother died of pancreatic cancer when she was just 55. And while my poor genes certainly factored into my calculations, my quality of life did as well.

Losing my parents so young taught me that we are not promised tomorrow. Living each day to its fullest matters — and I was not living my best life. My work was suffering, my mental health was suffering and some of my closest relationships were suffering. For me, the slight risk that HRT was reported to carry was worth it.

“It is always a personalized conversation,” Margolis added. “So much nuance goes into whether HRT is appropriate for a woman or not. Like any medication, there is risk involved … but to sleep is a good thing. To not almost kill people on a daily basis is a good thing.”

Turns out, HRT might not be so risky after all.

Earlier this month, the Food and Drug Administration announced it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments that are prescribed to ease the symptoms of menopause and perimenopause. Why? Because several subsequent studies have found the risks identified in the 2002 study were misrepresented.

According to the FDA, the average age of women in that study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer commonly used.

The news of the black box label’s removal has been heralded by many in the health care community as a big win for women’s health. It’s a first step in helping to remove the stigma HRT has carried over the past two decades and, hopefully, gives more women — and medical practitioners — the confidence they need to consider hormones as an effective treatment for perimenopause and menopause.

“This is lifesaving care,” said Indy Lane, M.D., vice president of women’s health at Allina Health. “Women are often focused on breast cancer risks and we want all women to be aware of those risks, but it’s also true that 1 in 3 women die of cardiovascular disease. We know (now) that HRT can reduce that risk if started at the appropriate time.”

Women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in mortality and fractures, the FDA noted in its news release about the black box label removal. 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%.

While Lane is encouraged by the FDA’s removal of the black box label and subsequent endorsement of HRT’s benefits, she says that in some ways, the damage has already been done.

“The Women’s Health Institute came out with their study in 2002, so you have a generation or two of physicians that have never been trained around the merits of HRT,” she said.

Lane herself finished her medical training in 2004, just two years after the study came out. But in 2016, after seeing so many midlife women desperate for help at her practice, she and a few of her colleagues went back for additional training on menopause.

“We just felt there had to be something we could do to better help women,” she said.

Still, as I wrote in my last column, there remains a shortage of providers trained on menopause and HRT. The FDA’s removal of the black box warning doesn’t change that — not right away anyway.

“It’s going to take some work to get everyone rowing in the same direction,” Lane said. “It will take providers understanding how to better treat women in this phase. It will take medical schools and systems to embrace what we know about HRT and begin teaching all their students. Not just doctors, but nurse practitioners, too, so that we are all armed with the info we need.”

It’s probably worth noting that because my regular doctors didn’t seem willing or knowledgeable enough to prescribe me HRT when I made the decision to go that route, I went through Midi Health, a virtual women’s health clinic specializing in perimenopause and menopause. The experience was truly wonderful and I’ve used them for other things since then, too.

“The most important thing is for women to not give up,” said Lane. “I understand the frustration and the time it takes. If you have a provider who is not willing to have a conversation with you, keep looking. There are providers that can help you. You deserve more. You shouldn’t have to suffer.”

Hear, hear. After all, you only live once.

(If you’d like to join a community of women discussing menopause, check out the Menopause Mentorship Circle, a Facebook group I launched earlier this year to accompany this column.)

about the writer

about the writer

Nicole Garrison

Contributing columnist

Nicole Garrison is a contributing columnist for the Minnesota Star Tribune focusing on menopause and women's health. She is a Twin Cities marketing and communications executive and a former journalist. She can be reached at menopausedinmn@gmail.com.

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