Menopausal women spent years unable to get relief from the potentially deadly but often preventable effects of recurrent urinary tract infections, due to the FDA’s black box warning for estrogen products. Despite growing evidence supporting safety and efficacy, and the lifting of the warning, a lingering stigma is keeping women from life-saving care.
Grave ‘misinterpretation’
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,” said USA Today. For menopausal women, those infections are also “more likely to spread to the bloodstream,” causing “sepsis, organ failure and death.”
For years, major medical groups have recommended a low dose of vaginal estrogen to help “prevent recurrent infections” in menopausal women, said USA Today. The cream, tablet or ring can “cost as little as a few dollars a month.” Unfortunately, for nearly two decades, access was limited by the government.
A set of Women’s Health Initiative (WHI) trials, launched in 1991, suggested that some forms of hormone therapy that included estrogen and progesterone could “increase the risks of cardiovascular problems, breast cancer, endometrial cancer and possibly dementia,” said Harvard Medical School. A “misinterpretation” in 2002 of that landmark research study prompted the FDA to “slap its strongest warning” on all estrogen products, including “low-dose vaginal estrogen” that was never studied in the associated trial, said USA Today. Shortly after, the FDA implemented a black-box warning, its “strongest available measure short of removing a drug from the market,” on all menopause treatments containing estrogen.
The stringent 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 for two generations of women,” said USA Today. Even when groups like the Menopause Society suggested in 2004 that “hormone replacement therapy, including vaginal estrogen, could be used for serious menopause symptoms,” the FDA black-box warning “kept most women from using it.” Many years later, researchers would say the study “overstated the risk of cancer for younger menopausal women,” leading to the FDA removing the black box warning in November 2025.
Deadly UTI’s still plague menopausal women
Nearly a year has passed since the warning was removed from vaginal estrogen and other estrogen products. But the treatment’s “use still isn’t widespread,” likely due to ongoing stigma, said USA Today.
The first Baby Boomers “turned 54 in 2000,” and estrogen use plummeted from “27% of menopausal women in 1999 to 5% in 2020,” according to the National Institutes of Health, said USA Today. During a similar period, between 1999 and 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 included in the June 2026 edition of the International Journal of Gynecology and Obstetrics.
This was more than “women simply suffering from hot flashes because they weren’t prescribed estrogen,” said Rachel Rubin, a urologist and menopause specialist, to USA Today. “They were dying.”
Vaginal estrogen has been shown to be an effective treatment for menopausal women with frequent UTIs. In a recent study published in the Urology Journal of nearly 2 million women with recurrent UTIs, “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,” said USA Today. Their recorded rates of sepsis and death were “roughly one-fifth as high.”
Despite that evidence, “only about 1 in 10 menopausal women covered by Medicare use vaginal estrogen,” according to records reviewed by USA Today. Unlike menopause hormone therapy, which is “widely prescribed,” vaginal estrogen suffers from a “public relations problem,” said The Center for Infectious Disease Research and Policy, with “few women knowing what it is.”
The black-label warning may be gone, but the stigma still endangers older women
