A Long-Overdue Reset: The FDA’s HRT Label Change
Medically Reviewed by Dr. Shaya Taghechian
Urogynecology / Women’s Pelvic Health Specialist
Georgia Urology
In collaboration with Aayla
Conversations about hormone replacement therapy (HRT) have carried a degree of hesitation for many years – on both sides of the exam table. That’s largely because FDA black box warnings broadly framed hormone therapy as high-risk, despite growing evidence to the contrary.
The FDA’s recent decision to remove those warnings doesn’t signal a sudden endorsement of hormone therapy for everyone, nor does it erase the need for thoughtful prescribing. What it does allow is clarity, leading to more accurate, individualized discussions in the exam room.
For patients navigating menopause-related urinary and vaginal concerns, this opens the door to clearer answers and more informed care.
One Study, Two Decades, and What We’ve Learned Since
Black box warnings for HRT can be traced back to the WHI (Women’s Health Initiative) trials from the early 2000s.¹ This research was designed to evaluate whether systemic hormone therapy could prevent chronic disease in an older population, not to study symptom management in women newly entering menopause. Participants were, on average, in their 60s and 70s, and many had existing cardiovascular risk factors. The life stage and associated health concerns of a woman in her 50s (the age range of patients who typically seek hormone therapy today) differ substantially from those of the WHI trial participants.
When early analyses of these trials suggested higher rates of breast cancer, cardiovascular events, and stroke in certain study arms, the findings were widely publicized and prompted sweeping regulatory action. FDA black box warnings were applied broadly across hormone products, without meaningful differentiation between systemic and local therapies or between older and younger patient populations.
What became clear over the last two decades is that those conclusions were overgeneralized. Subsequent studies and literature reviews have shown that the risks observed in the WHI trials were closely tied to specific factors: participants’ age and related health concerns, the timing of hormone initiation relative to menopause, and the formulations and doses used at the time. These findings do not translate directly to contemporary hormone therapy, particularly when treatment is initiated earlier in menopause or when low-dose, localized therapies are used.
The FDA’s decision to update black box warning labels followed an extensive review of evidence, including input from expert panels and alignment with specialty societies in urology, urogynecology, and women’s health. The agency refined its position to better reflect current data: hormone therapy is a nuanced intervention, and its risk-to-benefit ratio depends on the type of therapy (estrogen alone versus combination therapy, systemic versus local), the patient, dosages, coexisting health factors, and the overall clinical context.
By removing overly broad warnings, the FDA has helped correct a mismatch between labeling and evidence, supporting more precise, patient-specific decision-making and discussions.
More Than Hot Flashes
Hot flashes, night sweats, and mood changes steal the spotlight when we think of menopause, but the declining estrogen levels that bring on menopausal symptoms affect multiple systems, including the brain, musculoskeletal system, skin, and genitourinary tract.
Estrogen, progesterone, and testosterone levels affect reproductive, metabolic, and urologic function throughout a woman’s life. During reproductive years, estrogen dominates the sex hormone scene. It interacts with other processes in the body to help regulate sleep, mood stability, overall energy levels, and the ability to maintain healthy tissue function.
Progesterone’s job is to regulate the menstrual cycle, prepare the uterus for pregnancy, and prevent early contractions. As women transition into menopause, levels of both estrogen and progesterone decline, creating a cascade of physiological changes that can manifest as genitourinary symptoms that collectively contribute to what is now recognized as genitourinary syndrome of menopause (GSM).
There are estrogen receptors throughout the vagina, vulva, and urethra, and as estrogen levels fall, these tissues undergo structural and functional changes: the vaginal epithelium becomes thinner and less elastic, lubrication decreases, blood flow is reduced, and the local microbiome shifts. Symptoms of GSM include vaginal dryness, burning, and irritation; pain with sexual activity; recurrent urinary tract infections; urinary urgency and frequency; and certain forms of urinary incontinence.
HRT directly targets the hormones and subsequent tissue changes responsible for many of these complaints by improving tissue thickness, elasticity, and blood flow. For patients whose symptoms extend beyond the genitourinary tract, systemic hormone therapy also contributes to broader symptom relief, depending on individual needs and risk profiles.
It isn’t part of HRT in women, but testosterone deserves a plug here since it’s responsible for libido, sexual arousal, and the maintenance of genital tissue integrity, including vascularization and muscular tone in the pelvic floor. Natural declines in testosterone occur with age, in both men and women. While there are no FDA-approved testosterone therapies for women, it does have “off-label” indications for treating women with Hypoactive Sexual Desire Disorder (HSDD). (You can read more about testosterone therapy in women here.)
Silence is No Longer Acceptable
For too long, the combination of fear, outdated warnings, and misinformation has kept important conversations about hormone therapy off the table. Many women experiencing vaginal discomfort, urinary urgency, recurrent infections, or sexual pain have endured their symptoms, believing that treatment options were limited or unsafe. The FDA’s updated labeling changes challenge that assumption, empowering clinicians to address these issues openly and with evidence-based guidance.
Clinically supported ways to improve tissue health, urinary function, sexual comfort, and overall quality of life do exist. Modern therapy is tailored: dosage, delivery method, and timing are calibrated to a patient’s age, symptoms, and risk profile. An open conversation is especially relevant for patients with GSM. Untreated, it progresses and can contribute to recurrent urinary tract infections, urgency, frequency, incontinence, sexual pain, and plain interfere with daily life.
Your concerns deserve attention, and it’s no longer acceptable to hedge the conversation as the barriers come down. At Georgia Urology, we are equipped to evaluate, diagnose, and guide evidence-based treatment for hormone-related and genitourinary concerns. Open the conversation with your clinician to safely and effectively tend to your urologic health and restore your quality of life.
Women’s Hormone & Menopause Care at Aayla
Through Aayla, Georgia Urology’s dedicated women’s hormone and menopause care initiative, Dr. Shaya Taghechian provides expanded education and treatment pathways for women’s sexual wellness and intimate concerns.
Learn more about Aayla’s menopause and hormone therapy services here: https://aayla.com
Resource:
- U.S. Food and Drug Administration. (2025, November 19). FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations.
