Misleading monographs? These doctors say estrogen creams are safe and should be viewed that way

Dr. Ashley Winter, a urologist based in Los Angeles, considers vaginal estrogen creams to be wonder products. With genitourinary syndrome of menopause—which leads to vaginal atrophy and frequent urinary tract infections (UTIs), among other issues—impacting as many as 84% of women, she sees such creams as a low-cost way to keep older women healthier.They combat the symptoms of the syndrome, and have been shown to prevent UTIs. Since UTIs in older patients have a mortality rate of up to 33%, estrogen creams can even save lives.But you’d never know research has found these prescription products to be safe. In Canada, government-approved monographs come with a black-box warning of increased risk of “stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women,” among other concerns.“In literally study after study after study, there is proof that these creams don’t cause any of these things whatsoever. It does not cause them,” says Dr. Winter, who’s been active on X and TikTok trying to get the word out about the similar black box warnings on products sold in the U.S. “They’re not just safe, but there’s harm in not using these creams. Women can die from not using them. It makes me so upset,” says Dr. Winter, who thinks these creams could save healthcare dollars, too. “Product monographs and inserts that talk about breast cancer and cardiovascular disease and stroke and venous thromboembolism have no right being with that product. There's no evidence that there’s a connection,” says Dr. Michelle Jacobson, a menopause specialist in Toronto.Monographs cite data related to oral preparations, not creams. They omit relevant research, including a 2018 report using data from the Women’s Health Initiative Observational Study, which followed more than 45,000 women over seven years and found those who used creams had no increased risk of stroke, breast, colorectal and endometrial cancer and pulmonary embolism. As well, these women actually experienced lower risk of coronary heart disease, fracture and mortality.Another study, from 2024, looked at nearly 50,000 women with newly diagnosed breast cancer and found use of vaginal estrogen creams had no impact on risk of breast cancer-related death over the course of several years.These favourable studies have influenced standard of care. The society of Obstetricians and Gynaecologists of Canada’s published guidelines in 2017 clearly recommending vaginal estrogen for postmenopausal women for recurrent UTIs. The North American Menopause Society published an endorsement of such creams in 2020. In the U.K., vaginal estrogen tablets are sold over the counter. Vaginal estrogen creams contain about 1/1000 of the hormones contained in oral hormone replacement therapy. “I tell my patients, this is local use of hormones, they don’t enter the bloodstream in any significant way,” says Dr. Shafeena Premji, a family physician and Menopause Society Certified Practitioner based in Calgary. Both she and Dr. Jacobson serve on the board of the Canadian Menopause Society.These misleading monographs may contribute to a lack of understanding regarding the safety and efficacy of these creams.“When we prescribe treatments for the genitourinary syndrome of menopause, there are barriers to completing the cycle of them going to the pharmacy, picking up the medication, being spoken to by the pharmacist, opening the product monograph, and then actually using the treatment,” says Dr. Jacobson.She speaks frequently to physicians about the syndrome and creams, and sees a lack of awareness. “This is a chronic condition that will only get worse over time, whereas the other symptoms of menopause tend to get better the further away from menopause you get,” says Dr. Jacobson. Dr. Premji says a loss of sexual function is a common aspect of the syndrome. “I see this every single day. It can put a damper on a marriage. Women are already feeling stressed and you add this on top of everything, it’s a thunderstorm. But unlike many of the other issues that happen during menopause, this can be treated easily.”She says IntraRosa, which contains DHEA and has been on the market since 2020, has no black box warning, and can be used for dyspareunia and UTI prevention. Dr. Premji welcomes more choice, as patients hesitate to start using creams and stick with them. “They’ll give up after one month, they think they don’t need it anymore. I’m telling patients this is not risky to be on when you’re 50, 60, 70 or 80.”She compares using vaginal creams to taking blood pressure medication: it’s probably for life. Dr. Jacobson similarly suggests women should expect to use them for decades. “Most people who know what they’re talking about say they’re going to use it to the grave. It’s a no brainer.”The North American Menopause Society and other health advocacy groups in the U.S. are trying to change monographs for these products; they’ve set up a meeting with the Food and Drug Administration (FDA) for June 27.“We have to talk about using vaginal estrogen as a life-saving issue; it’s not just about vaginal dryness,” says Dr. Winter. In 2016, the organization petitioned the FDA on this issue and was turned down two years later.With more published studies confirming the safety and benefits of these products, there might be an opportunity for a different outcome. In Canada, meanwhile, there’s no current plan to argue for a change. “We have other fish to fry,” says Dr. Jacobson, who says there are numerous other advocacy priorities in women’s health.But she is still enraged about the misinformation on monographs. “To me it actually feels quite calculated, and quite dismissive of the importance of women's health concerns,” says Dr. Jacobson.Dr. Winter, likewise, has strong words about government rules scaring women off a much-needed product. “It’s just lies. It’s bad.”

Misleading monographs? These doctors say estrogen creams are safe and should be viewed that way

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