In a long-overdue move, the FDA recently brought together a panel of 12 national experts—including endocrinologists, urogynecologists, and orthopedic surgeons—to take a closer look at the current labeling of hormone therapy used in menopause. One of the biggest points of discussion? The black box warning on vaginal estrogen products, which cautions against increased risk of stroke, heart attack, and dementia.
This warning has been a source of frustration for years among menopause experts, who point out that these risks do not apply to vaginal estrogen. And yet, the label remains, and women are paying the price.
This panel brought critical attention to what needs to change. Here are a few key takeaways from the conversation:
1. Science and safety labels must match.
There’s a growing disconnect between what research tells us and what product labels still say. While some global regulatory agencies now recognize vaginal estrogen as safe and effective, others—including the FDA—have not updated their labeling. This inconsistency causes confusion for both patients and providers, and often prevents women from receiving the care they need.
2. Hormone therapy should be personalized.
Menopause is not a one-size-fits-all experience, and neither is hormone therapy. Factors such as dose, delivery method, formulation, and timing all impact how hormones function in the body. Unfortunately, many of the studies that continue to inform public policy (including the well-known 2002 Women’s Health Initiative study) didn’t consider these differences, leading to oversimplified and sometimes misleading conclusions.
3. Outdated warnings are costing women—and the system.
Vaginal estrogen is one of the safest and most effective ways to treat genitourinary symptoms of menopause, including recurrent UTIs. It’s also highly cost-effective: among older adults, more widespread use could reduce ER visits and hospitalizations, saving the healthcare system billions of dollars.
What This Means for Our Patients
At true., we’ve seen the impact of outdated warnings and misinformation firsthand. Many women come to us after being denied appropriate treatment by multiple providers. Others have turned to compounded, unregulated hormone therapies that are not evidence-based and may not be safe.
We’re here to do better.
Our providers are experts in women’s health and menopause medicine. Every clinician on our team is trained in the latest science, and Dr. Diana Bitner, Dr. Celia Egan, and Susanne Pettigrew are certified by The Menopause Society, the global leader in menopause research and education. (Dr. Tricia Mueller and Megan Mouser, NP, are soon to be certified as well!) You can trust that the care you receive here is based on what the science says—not outdated fear.
The Bottom Line
Women deserve access to accurate information and the safest, most effective treatment options available. We can’t undo the harm that’s been caused by years of misinformation—but we can change the future. By continuing to advocate, invest in research, and offer expert, evidence-based care, we’re helping pave the way for a better menopause experience for all women.
“We all deserve a good menopause.” – Dr. Diana Bitner
Want to watch the panel discussion?
Catch the full recording here: Watch on YouTube