'Women deserve an apology': For menopause, hormone therapy is now considered safe - just in time for aging millennials

By Jaimy Lee

The FDA no longer requires a safety warning on hormone-replacement therapies, at a time when more attention is being paid to perimenopause and menopause

Menopause care has long been a casualty of bad science and a lack of attention, but now, therapies fueled by advancing research, a flood of investment money, celebrity advocacy and regulatory changes could make menopause a different experience for millennial women than it was for previous generations.

There is now broad consensus among U.S. regulators, physician-scientists and menopause doctors that hormone-replacement therapies are safe and effective countermeasures against the symptoms of menopause and perimenopause. These symptoms include hot flashes, insomnia and brain fog. HRT provides women with bioidentical estrogen that their bodies no longer make regularly or at all, in addition to progesterone in most cases.

But few women in the U.S. use HRT, driven by a decades-old misplaced fear that the therapies raise the risk of breast cancer. The reluctance to use HRT is the result of a controversial 2002 study that identified an elevated risk of invasive breast cancer in postmenopausal women.

The Women's Health Initiative study "impacted people's ability to get a really life-changing medication," said Mindy Goldman, chief clinical officer at Midi Health. "Because the risks at that time were felt to be greater than the benefits, the fallout from that was to tell women, just deal with the symptoms - that they will get better with time."

Midi Health, a startup that provides virtual menopause care, is a key player in the new menopause market. It raised $50 million in 2025, a year in which funding and research into menopause exploded. Actor Amy Schumer is an investor, as is Meghan, the Duchess of Sussex. Celebrities like Naomi Watts and Halle Berry have spoken publicly about menopause while also launching menopause brands and advocating for new laws. Dozens of bills have been introduced at the state level. There are nonhormonal treatments, while new research has renewed the role of HRT, even among people at higher risk of breast cancer.

There is now a growing understanding that treating menopause, whether hormonally or otherwise, improves quality of life and may stave off many conditions associated with aging in women, such as heart disease, osteoporosis and cognitive decline. And since women use GLP-1 medications at a higher rate than men, investors are now well aware that women are driving the most "profitable category of the most profitable industry on the planet," according to Jessica Federer, managing director of the Women's Health Fund.

"All of these developments reflect years of work behind the scenes, but they are hitting the public zeitgeist now," Federer said. "The years of laying the groundwork [are] finally paying off."

The FDA is responsible for two major events. It recently approved Bayer's (XE:BAYN) Lynkuet, the second nonhormonal treatment for hot flashes after Astellas's (JP:4503) Veozah.

Around the same time, the regulator announced that it was lifting black-box warnings on some HRT products that had notified patients about risks of heart disease, breast cancer and probable dementia and that were put in place the year after the Women's Health Initiative study came out.

Physicians have long questioned the study's design, particularly in regards to the age of the women enrolled in the trial. The study of 16,608 postmenopausal women taking HRT mostly looked at women between the ages of 50 and 79; the average age was 63. Menopause typically occurs around age 51 in the U.S., while perimenopause can start in a woman's 30s or 40s.

Following the study, women largely stopped using the medications. In 1999, 26.9% of women in the U.S. who were in menopause used HRT. By 2020, that percentage had dropped to 4.7%.

"Women deserve an apology," wrote FDA Commissioner Marty Makary, who devoted a chapter to HRT in his 2024 book, "Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health."

But changing labels on certain HRT products isn't the only way menopause care is evolving. Millennial-friendly providers like Hims & Hers Health (HIMS) and Amazon's (AMZN) One Medical have launched dedicated menopause and perimenopause offerings, as has Weight Watchers (WW).

There's also been a wave of new research aimed at personalizing care. In September, a study in JAMA Internal Medicine re-analyzed the Women's Health Initiative research, finding that HRT can relieve vasomotor symptoms like hot flashes in younger postmenopausal women but that it should be stopped by the time they reach age 70. (Hot flashes can increase the risk of heart disease.)

Another study, published in December, found that women with BRCA gene mutations, which carry an elevated risk of certain cancers, can safely use HRT, opening the door for a group of people who thought the therapies were off the table.

"It's a huge step in the right direction of improving women's health," Midi's Goldman said.

-Jaimy Lee

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01-08-26 0714ET