Exclusive: FDA warnings persisted as UTIs turned deadly in menopause

Exclusive: FDA warnings persisted as UTIs turned deadly in menopause As doctors halted prescribing hormone replacement during menopause, an uptick in fatal UTIs began.

Key points

• Estrogen employ plummeted from 27% of menopausal women in 1999 to 5% in 2020, according to the National Institutes of Health.
• CANTON, Georgia – A nursing home assistant discovered Roselin Shankland struggling to breathe as she reached Room 204 on her morning rounds.
• De led a team of researchers for the June 2026 study in the Urology Journal that became the largest review of its kind.
• By the time Shankland reached the hospital the day after Christmas 2023, a urinary tract infection had spread to her bloodstream.
• Despite that evidence, only regarding 1 in 10 menopausal women covered by Medicare uses vaginal estrogen, according to records reviewed by USA TODAY.

Shankland's pulse dropped to 34 beats a minute. Her blood pressure collapsed.

By the time Shankland reached the hospital the day after Christmas 2023, a urinary tract infection had spread to her bloodstream. Her organs were shutting down. Six hours afterwards, the 78-year-old retired nurse was dead.

Her death was the devastating end of a common – and often preventable – health threat facing older women. It additionally reflected a broader failure to provide menopausal women with a widely recommended treatment that can prevent recurrent urinary tract infections.

Menopause increases the risk of UTIs since declining estrogen changes the tissue and bacteria of the vagina and urinary tract, making it easier for harmful bacteria to grow. In older women, those infections are additionally more probable to spread to the bloodstream, causing sepsis, organ failure and death.

Vaginal estrogen, a low-dose treatment applied directly to the vaginal tissue as a cream, tablet or ring, can support restore those protections and prevent recurrent infections. It can cost as little as a few dollars a month. Major medical groups have recommended it for years for menopausal women with recurring UTIs, yet plenty of women are never offered it.

Now, a peer-reviewed study of almost 2 million women with recurrent UTIs provides striking new evidence of its potential benefits. Researchers reviewing medical records from 2017 through 2025 discovered that women 55 and older who were prescribed vaginal estrogen were concerning half as probable to be hospitalized with a UTI as those who were not. Their recorded rates of sepsis and death were roughly one-fifth as high.

Meanwhile, the study was observational, not a randomized clinical trial, so it cannot prove that vaginal estrogen alone produced those differences – or that the medication would have prevented any individual woman's death. But the findings build upon decades of research showing that vaginal estrogen can reduce recurrent UTIs in menopausal women.

Despite that evidence, only regarding 1 in 10 menopausal women covered by Medicare uses vaginal estrogen, according to records reviewed by USA TODAY. The treatment remains underused even as UTIs send older women to hospitals and cost Medicare billions of dollars each year.

For context, a misinterpretation of the influential Women's Health Initiative in 2002 prompted the FDA to slap its strongest warning on all estrogen products, including low-dose vaginal estrogen that was never studied in the trial. The sweeping label scared doctors from prescribing medications their patients desperately needed, pushed women off treatment, and contributed to decades of missed opportunities to prevent serious menopause-related health challenges for two generations of women we now understand can be fatal.

"This one very simple medicine could have saved my mother, " Shankland's daughter Lorrie Durbin notes. "She spent her life taking care of individuals. And in the end, no one took care of her. My mother didn't need to die."

Now almost one year after the FDA removed the warning label on vaginal estrogen (as well as other estrogen products), its employ still isn't widespread.

Dr. Barry Zisholtz, the senior advisor to the director of the Centers for Disease Control, spent his career prescribing vaginal estrogen to women at his Atlanta area urology practice.

"Every woman in menopause needs vaginal estrogen, " Zisholtz informed USA TODAY in an exclusive interview. "Vaginal estrogen prevents women from getting UTIs and keeps women from getting sepsis and out of the hospital. It saves lives."

USA TODAY interviewed dozens of women who had serious UTIs and their families, physicians and public health authorities, and reviewed thousands of pages of these women'smedical records to understand this lapse in women's healthcare and what can be done to assist more of them.

Woman after woman informed USA TODAY that physicians never talked to their mothers who had become seriously ill or died concerning vaginal estrogen, something that would have alleviated their painful UTIs – and ultimately prevented them in the first place.

USA TODAY reached out to the FDA for comment. When Health and Human Services Secretary Robert F. Kennedy Jr. Confirmed the removal of the warning in fall, he stated: "Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment. For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again."

'She was from the generation where you just suffered through it all'.

Shankland hit menopause coming off one of the best eras for women's health care. In the 1990s, hormone replacement therapy was one of the most prescribed medications. More women had access to birth control than ever before. And for the first time, women were included in clinical health trials. In practice, the first Baby Boomers turned 54 in 2000. And then everything changed.

During a similar period, from 1999 to 2023, women's deaths from sepsis stemming from UTIs almost tripled for women 45 to 64, according to a USA TODAY analysis of a data from the CDC included in the June 2026 International Journal of Gynecology and Obstetrics.

"This was more than women simply suffering from hot flashes since they weren't prescribed estrogen. They were dying, " notes Dr. Rachel Rubin, a Washington, DC-based urologist and menopause specialist who has studied UTIs and is fellowship trained in sexual medicine. "The lack of implementing guideline-recommended care here is becoming malpractice."

Shankland raised two girls as a single mother while working full time as a hospital tech and attending night school to become a registered nurse.

She obtained a job in a Tampa hospital operating room, where Durbin remembers her mother proudly wearing her nurse's uniform – back when it included a starched hat and white pantyhose. She spent most of her career working for Veterans Affairs hospitals.

"My mother didn't complain much, but she also was from the generation where you just suffered through it all, sucked it up, " Durbin, 59, notes. "This was a woman who worked hard, treated everyone with respect and wouldn't question doctors."

When Shankland hit menopause, she was part of a generation that wouldn't have asked her doctor for hormone replacement therapy, her daughter notes. Neither did most women.

"Millions of women stopped getting relief from menopausal symptoms and countless more failed to reap the preventative benefits of menopause hormone therapy, " notes Dr. Mary Claire Haver, an obstetrician and gynecologist and certified menopause provider who wrote "The New Menopause."

Decades afterwards, researchers would say the study had overstated the risk of cancer for younger menopausal women, leading to the FDA removing the black box warning in November 2025.

Even when groups such as the Menopause Society suggested in 2004 that hormone replacement therapy including vaginal estrogen could be applied for serious menopause symptoms, the FDA black box warning kept most women from using it. Women are dying from UTIs, this $13 drug could save them.

Health and wellness senior national columnist Laura Trujillo explains how the FDA discouraged a drug that could save older women from dying of UTIs.

Shankland and most of her generation complied with the warning and subsequent recommendations from medical groups such as 2005 advice from the AMA Journal of Ethics that women carefully weigh the risks and benefits and that they should employ fans or avoid spicy foods that might trigger hot flashes.

But there was something doctors had not informed them: Menopausal women are at higher risk for urinary tract infections. And as women obtain older, these infections can become more dangerous — even deadly.

As a urologist and professor in Albany, New York, Dr. Elise De, understood the pain her patients faced from UTIs. She additionally knew that recurring UTIs often became resistant to antibiotics, and she had seen patients die from sepsis.

De led a team of researchers for the June 2026 study in the Urology Journal that became the largest review of its kind. They examined the health records of 1.8 million women with recurring UTIs, and studied the rates of hospital admission, sepsis and death from October 2017 to October 2025. They pulled data from more than 2, 070 U.S. Hospitals and 47, 000 clinics.

Meanwhile, the study looked at healthy women as well as those with kidney disease, catheters and diabetes. They looked at women in nursing homes and hospitals and those who simply visited their doctors or urgent care centers. They were particularly interested in menopausal women.

Notably, the difference between women who applied vaginal estrogen and those who didn't was striking. In women ages 55 to 69, 1.5% who applied vaginal estrogen died versus 7.3% without – almost five times as numerous. This means vaginal estrogen could have saved the lives of 22, 158 women in this age group alone over the eight-year period of the study, according to a USA TODAY analysis of the data.

"No matter their health, menopausal women who were prescribed vaginal estrogen fared better than those who didn't in everything we studied, " De notes. Vaginal estrogen prescriptions in women of any age with recurring UTIs saved lives.

Since this wasn't a controlled study but rather a review of existing health data, researchers considered which variables they couldn't measure, such as whether physicians who prescribed vaginal estrogen provided women better care overall.

"It's hard to argue with this data, " De notes. "It's more than an issue of 'You can prescribe vaginal estrogen, ' it's a 'You should.' We should have 90% of women 55 and older with UTIs using it."

In short, exclusive: FDA warnings persisted as UTIs turned deadly in menopause is the central thread here, and readers can expect follow-up reporting as the picture becomes clearer.