Exclusive: FDA Warnings Persisted as UTIs Turned Deadly in Menopause

USA TODAY Network / Reuters

CANTON, Georgia – A nursing home assistant found Roselin Shankland struggling to breathe as she reached Room 204 on her morning rounds. 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 later, 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 also reflected a broader failure to provide menopausal women with a widely recommended treatment that can prevent recurrent urinary tract infections.

Why UTIs Become More Dangerous After Menopause

Menopause increases the risk of UTIs because 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 also more likely to spread to the bloodstream, causing sepsis, organ failure and death.

Vaginal estrogen, a low-dose treatment applied directly to vaginal tissue as a cream, tablet or ring, can help 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 many women are never offered it.

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

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 about 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.

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 problems.

This article discusses medical treatment and does not replace advice from a qualified health professional. Talk with your clinician about your symptoms, medical history and treatment options.

How the Evidence Changed

Now almost one year after the FDA removed the warning label on vaginal estrogen, its use still isn’t widespread.

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

USA TODAY interviewed dozens of women who had serious UTIs and their families, physicians and public health officials, and reviewed thousands of pages of medical records to understand this lapse in women’s health care and what can be done to help more women.

Women told USA TODAY that physicians never talked to their mothers who had become seriously ill or died about vaginal estrogen, something that might have alleviated painful UTIs and helped prevent them.

When Health and Human Services Secretary Robert F. Kennedy Jr. announced the removal of the warning in fall 2025, he said the change would give women and physicians a more complete view of hormone replacement therapy. The FDA has retained a warning for endometrial cancer for systemic estrogen products.

What the Study Found

Estrogen use plummeted from 27% of menopausal women in 1999 to 5% in 2020, according to the National Institutes of Health. During a similar period, from 1999 to 2023, women’s deaths from sepsis stemming from UTIs nearly tripled for women 45 to 64, according to a USA TODAY analysis of CDC data published in the June 2026 International Journal of Gynecology and Obstetrics.

Researchers examined the health records of 1.8 million women with recurring UTIs and studied hospital admission, sepsis and death rates from October 2017 to October 2025. They pulled data from more than 2,070 U.S. hospitals and 47,000 clinics.

The study looked at healthy women as well as those with kidney disease, catheters and diabetes, including women in nursing homes and hospitals and those who visited doctors or urgent care centers.

In women ages 55 to 69, 1.5% who used vaginal estrogen died versus 7.3% who did not – almost five times as many. According to a USA TODAY analysis, vaginal estrogen could have saved the lives of 22,158 women in this age group over the eight-year period of the study.

Because this was a review of existing health data rather than a controlled study, researchers considered variables they couldn’t measure, such as whether physicians who prescribed vaginal estrogen provided better care overall.

What Patients Should Ask About

UTIs can cause delirium in some older women and are sometimes mistaken for dementia. In other cases, delirium from a UTI can lead to falls and broken bones. Women with recurring infections can ask their health care providers whether vaginal estrogen is appropriate for them.

Vaginal estrogen can be prescribed in several forms, including a cream used twice weekly, inserts or a ring replaced every few months. Systemic estrogen, often delivered in a patch, may help with bone loss but does not help prevent UTIs, researchers say.

The American Urological Association, the Menopause Society and the American College of Obstetricians and Gynecologists recommend vaginal estrogen for menopausal women, especially those with recurring UTIs. The treatment may not be appropriate for everyone, and a clinician can discuss risks and benefits.

Most doctors – even gynecologists – haven’t received adequate menopause training, according to a study in the Journal of The Menopause Society. Less than one-third of nearly 100 obstetrics and gynecology residency program directors surveyed said they were taught how to treat menopause symptoms during residency.

The USA TODAY analysis found one provider specializing in menopause for every 11,000 women 50 and older in the U.S. There are now almost 6,000 certified menopause care professionals, most of them physicians, up from 1,000 nearly a decade ago.

What It May Cost

A three-month supply of generic vaginal estrogen cream through online drug sites can cost $13, while rings or inserts can cost up to $1,000 every three months, which may exceed many Medicare plans. Coverage and prices vary, so patients should check with their plan and pharmacy.

Medicare prescription coverage policy could help more women access the treatment, according to Jennifer Weiss-Wolf of New York University’s Birnbaum Women’s Leadership Center.

Sources: USA TODAY reporting; National Institutes of Health; Centers for Disease Control and Prevention; U.S. Food and Drug Administration; American Urological Association; The Menopause Society; American College of Obstetricians and Gynecologists.

 

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