Hormone drugs make $6.3 billion comeback after FDA nixes safety warnings

Lea Didion didn’t realize the night sweats she began experiencing in her 40s might be a sign of perimenopause.

Her doctor clued her in and suggested she consider hormone replacement therapy, a once-vilified treatment that has come roaring back to help relieve hot flashes, vaginal dryness and other symptoms women start to experience in mid-life.

Didion soon began seeing a flood of social media posts and news articles about the benefits of hormone therapy, especially as the Food and Drug Administration prepared to ask drugmakers to remove strict black box warnings that had been placed on the medicine since 2003 — product labels that the agency now says led to “fear and misinformation.” In the fall, she started on a weekly estradiol patch and a nightly progesterone pill.

“It’s been shockingly helpful,” the California resident, 45, said. The aches she assumed were just part of getting older disappeared, her energy level increased and her gut health improved. “Some crappy research has been hurting women for decades.”

Last year nearly 32 million prescriptions were written for estradiol, a form of estrogen that is used to treat menopause symptoms, compared with 18 million in 2021, according to Symphony Health data compiled by Bloomberg Intelligence. The rush for the hormones, mainly sold as patches placed on the skin, accelerated when FDA Commissioner Marty Makary took office last year and made it a priority, speaking out about how he believed outdated research had been keeping women from life-changing treatments. He’s asked drugmakers to tone down references to risks of cardiovascular disease, breast cancer and probable dementia on hormone therapy labels — a move to encourage women to discuss the treatments with their doctors and weigh their options more fairly.

Set against that cultural shift, the about-face from the nation’s leading drug regulator helped estradiol prescriptions surge 32% between 2024 and 2025 alone, creating a $6.3 billion windfall for generic drugmakers including Viatris Inc., Sandoz Group AG and Amneal Pharmaceuticals Inc. Estradiol patches are so hot right now that women are having trouble finding them at pharmacies.

Perimenopause — the transitional stage that precedes the end of a woman’s period and is defined by estrogen fluctuations — and menopause have become hot topics in the last few years. Celebrities including Gwyneth Paltrow, Halle Berry and Naomi Watts have shared their experiences to reduce stigma, and bestselling books like The New Menopause have guided women in managing symptoms and advocating for treatments.

Makary’s interest sprang from his mother’s experience — he says she was never offered hormone therapy — and his fascination with “the concept of medical reversals, medical dogma, new evidence,” he said in an interview with Bloomberg News. He wrote about hormone therapy in his book Blind Spots and talked about his views on podcasts and in public almost immediately after becoming commissioner.

“When you realize that 50 million-plus women may have been denied or talked out of hormone therapy,” he said, “you realize, given the profound long-term health benefits, that there has been a giant missed public health opportunity.”

The original research that raised alarm bells about hormone therapy was published in 2002 and conducted by the Women’s Health Initiative, which found an increased risk of developing breast cancer. But the average age of women in the study was 63 years — more than a decade past the average age of a woman starting menopause — and participants were given a hormone formulation no longer in common use, according to the FDA. The Menopause Society now says that the risks are low enough in younger women who are closer in age to their menopause transition that the benefits of hormone therapy can outweigh them.

Hormone therapy is “fairly safe,” said Lubna Pal, a professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine who specializes in menopause. The black box warnings were “unjustly put there in the first place.”

In recent years, patches have become the preferred way to use estradiol. The Menopause Society says absorption through the skin might be safer than passing through the liver, as a tablet requires, though more research is needed.

While the number of prescriptions for patches has risen sharply in line with the increase in estradiol prescriptions overall, prescriptions for tablets have remained fairly steady over the last decade. Patches — typically placed on the lower abdomen — were officially listed as in shortage on Jan. 30 by the American Society of Health-System Pharmacists, which tracks the drug supply.

Estradiol also comes in a vaginal cream that can relieve dryness and discomfort associated with sexual activity. Makary told Bloomberg the agency is working to make vaginal estrogen available over-the-counter so it can be bought without a prescription, given its “profound benefits” like preventing urinary tract infections and reducing painful sex. It’s a process that can typically take about six months, though Makary said he’d like to see the change sooner. Estradiol can help with a variety of symptoms, said Rachel Pope, chief of the female sexual health division at University Hospitals in Ohio, including sleep interruptions and thinning hair. Many of her patients also reported relief from aching joints.

Recently, 48 hours before her last estradiol patch needed to be replaced, Jessica Halem learned that her CVS in Massachusetts was out of stock. Her doctor switched her to a weekly version that the pharmacy still had available, instead of the twice-weekly one she had been using.

“It sucked,” Halem, 53, said. “I could immediately feel the difference.”

She planned to try an estradiol spray instead, but CVS told her that was also delayed. “I truly cannot believe this keeps happening,” she said.

Many women on estradiol also take a progesterone pill at night that protects their uteruses from any abnormal growth estrogen might cause. Prescriptions for progesterone pills increased to almost 14 million last year, up from 5.2 million in 2021, according to Symphony Health data compiled by Bloomberg Intelligence. The renewed excitement over the therapies is setting off some alarm bells in the medical community, with doctors worried that supplies could become even more constricted. “As that awareness continues to grow, the demand is only going up,” said Kathleen Jordan, chief medical officer of Midi, a telehealth startup focused on women in midlife that opened up shop in 2021, the same year estradiol prescriptions started steadily rising ahead of last year’s explosion. “I hope our pharmaceutical industry realizes this.”

The first menopausal hormone therapy was approved by the FDA in 1942. Almost 30% of postmenopausal women in the U.S. were on hormone therapy in 2001, the year before the now-refuted Women’s Health Initiative study came out.

The resulting black box warnings — the most stringent safety alert assigned by the FDA — led usage to plummet to as low as 4.7% in 2020 among postmenopausal women in the U.S., according to a JAMA Health Forum paper.

More women are accessing hormone therapy now, but Bloomberg data indicates it’s still only about 7% of those in the relevant age range. This means there’s a lot of room to grow. And given how old the drugs are, most are generic now, making them less expensive. Midi has tried to press drug manufacturers on those points, hoping to secure commitments to increase production, Jordan said. Viatris, Sandoz and Amneal told Bloomberg they were working to expand production, but didn’t respond to questions seeking additional details. Teva Pharmaceutical Industries Ltd. didn’t respond to questions about its estradiol. Viatris, Sandoz and Amneal are the top three patch sellers, while Teva sells mostly estradiol tablets.

With the safety warnings coming off many hormone therapy products, Makary said there’s more work to be done. He’s planning to convene a panel of experts to discuss the increased use of the treatments and the best candidates to take them.

The push from the FDA and increased supplies of the drugs could lead to even greater usage in the coming years — a welcome shift, doctors say, after years of skepticism from patients.

“Five years ago I was trying to convince women that they don’t have to suffer and they should try hormone therapy,” Pope said. Women now “want hormone therapy with no hesitation at all. It has changed a lot.”