Big News in Women’s Health: The FDA Removes the “Black Box” Warning from Estrogen Therapy
If you’ve been waiting for some good women’s health news… today is your day!!
Just a couple weeks ago, in a major step forward for women’s health, the FDA announced that it is removing the long-standing “black box” warning from most estrogen-containing hormone therapy products. This black box was added more than 20 years ago after early results from a randomized controlled trial run by the Women’s Health Initiative raised concerns about breast cancer, stroke, heart disease, and dementia. The results of this study were disproven years ago, but the stigma surrounding estrogen therapy remained.
Over the last two decades, research has become much clearer: original risks were overstated, misunderstood, and not applicable to many forms of hormone therapy, especially low-dose vaginal estrogen and systemic estrogen when started within 10 years of menopause or before age 60. After hearing updated evidence and expert recommendations, the FDA determined that the warning was misleading and unnecessarily discouraging women from safe, effective treatment. The only boxed warning that remains is the one related to endometrial cancer risk when estrogen is used alone in individuals with a uterus.
Why was the black box there in the first place?
Back in 2002, early results from a study run by the Women’s Health Initiative (WHI) suggested that estrogen therapy increased the risk of breast cancer, stroke, heart disease, and dementia. Those findings caused widespread fear, prescription rates plummeted, and stigma around estrogen therapy skyrocketed.
Even though those early results were later disproven, reanalyzed, and shown to be misunderstood or misrepresented AND the original conclusions didn’t apply to many of the most common forms of hormone therapy, fear amongst both providers and consumers remained. This led to an entire generation of medical doctors who weren’t trained how to prescribe hormone replacement therapies and a generation of women who wouldn’t have used it even if it were prescribed.
If you want to learn more about the history and controversy surrounding HRT, listen to this podcast interview between Dr. Rachel Rubin and Peter Attia. Dr. Rachel Rubin is a urologist and sexual medicine specialist who has been spearheading the movement to destigmatize estrogen therapies for years. She was instrumental in the removal of these unnecessary warnings and we have her and her colleagues to thank for this monumental shift!
Estrogen therapy has life-changing benefits for people in menopause.
After years of updated evidence and strong recommendations from leading experts, the FDA determined that the boxed warning was both misleading and unnecessarily frightening. By removing it, the FDA acknowledges what the science has shown for years: estrogen therapy, when used appropriately, is a safe and powerful tool for improving quality of life in menopause.
Estrogen therapy has been shown to help people in menopause by:
Reducing hot flashes and night sweats
Improving sleep
Preventing recurrent urinary tract infections
Improving vaginal dryness and pelvic floor symptoms
Supporting bone density
Enhancing overall quality of life
Why does this change matter so much to women of all ages?
This change is going to improve access to menopause symptom relief, reduce fear and stigma around hormone therapy, and encourage clinicians to prescribe estrogen based on current evidence, not outdated concerns. It’s going to lead to providers who are capable and willing to prescribe a life-changing treatment and a culture of patients willing to accept this medication without fear.
For many women, especially those struggling with hot flashes, sleep issues, vaginal dryness, and pelvic floor symptoms, this is a meaningful and long-awaited shift toward evidence-based, accessible care.
How can you access estrogen therapy?
Despite the removal of the black box warning, estrogen therapy is still a medical treatment that carries its own costs and benefits, unique to each individual’s health history and circumstances. With an increasing number of online retailers selling everything from GLP-1s to hormone replacement therapies, I still urge you to begin your conversation with a provider who knows you, your health history and goals.
If you don’t have a provider you trust, you can find a certified menopause practitioner near you using this resource created by The Menopause Society.
How do estrogen therapies support pelvic health?
During menopause, declining estrogen levels lead to important changes in the pelvic region, including thinning and dryness of the vaginal and vulvar tissues, reduced blood flow, and structural changes in the bladder and urethra, which are also highly hormone-dependent tissues. All of these changes can contribute to symptoms like painful sex, vaginal irritation, urinary urgency, recurrent UTIs, and pelvic pain. Estrogen therapies, especially local vaginal estrogen creams, help replenish the hormones these tissues rely on, improving bladder, bowel, and sexual health as a result.
Pelvic floor physical therapy plays a critical role by addressing muscle tension, weakness, coordination, posture, and movement patterns, but when the underlying hormonal environment isn’t supported, patients can sometimes reach a plateau in their progress. Hormone therapy and pelvic floor physical therapy are not competing treatments, they are complementary. When used together, they create a more complete foundation for healing by supporting both the musculoskeletal system and the health of the tissues themselves.
By supporting the integrity of the vaginal walls and the urinary system, estrogen can reduce pain, improve sexual comfort, and ease bladder symptoms, making a meaningful difference in pelvic health and overall quality of life during menopause. The removal of the black box warning is a huge step forward in reducing the friction for patients to access the care they need.
This post was written by Dr. Rebecca Maidansky, PT, DPT, owner and founder of Lady Bird Physical Therapy. Rebecca is a pelvic floor physical therapist in Austin, TX and founded Lady Bird Physical Therapy in 2019. She is the creator of Birth Preparation and Postpartum Planning, Baby Steps Fitness and the lead writer of the Lady Word, Lady Bird PT’s blog!
Rebecca is a passionate writer and vocal advocate for pelvic health and the importance of improving access to perinatal care. She believes strongly that many common pregnancy pains and postpartum symptoms can be eased or even prevented with basic education and care.