FDA to Remove Outdated Warnings on BHRT Medications
On Nov. 10, 2025, The U.S. Department of Health and Human Services announced that the FDA will remove the black box warning on HRT-related estrogen products that treat menopause in women.
These warnings were added in the 2000s due to a flawed study that claimed an increased risk of breast cancer diagnosis in HRT patients.
The FDA decided to remove them after reviewing the scientific evidence, accepting comments from the public, and hosting an expert HRT panel.
Issues with the study include:
The “increased risk” was statistically non-significant.
This means the study did not provide strong evidence that HRT directly caused increased breast cancer diagnosis.
The participants were 63 years of age on average.
Menopause typically starts around the age of 50, and HRT can be utilized as early as a woman’s late 30s if she’s experiencing perimenopause symptoms.
More recent studies show HRT offers significant benefits to women under the age of 60 and those who are less than 10 years into menopause.
Study participants were treated with hormone formulations that are no longer widely used.
This renders many of the conclusions irrelevant to today’s care plans.
The removal of these warnings allows for better treatment of menopausal women who are struggling.
Providers are now more empowered to help women optimize their hormones and reduce symptoms like low libido, fatigue, mood swings and irritation, vaginal pain, and more.
Defy Medical is pleased to see this label change on estrogen medications and hopes removing this under-researched claim will allow more women to access this life-changing treatment.
Read the ArticleWhat is Menopause?
Menopause is a natural biological process that marks the end of a woman’s reproductive years.
A woman is considered to be in menopause after 12 consecutive months without a period. During this time (often called perimenopause or premenopause), the ovaries gradually produce less estrogen and progesterone, leading to irregular periods before they stop completely.
Once a woman fully enters menopause, her ovaries no longer produce Estrogen and Progesterone.
This hormonal shift can cause a range of symptoms, including:
- Hot flashes and night sweats
- Mood changes and irritation
- Sleep disturbances and fatigue
- Vaginal dryness and pain
- Changes in metabolism and weight gain
What is BHRT?
BHRT stands for Bioidentical Hormone Replacement Therapy.
This treatment replaces Estrogen (typically in the form of estradiol or estriol) and Progesterone through topical creams, patches, injections, and other delivery systems. Some BHRT plans include other hormones like Testosterone and DHEA.
Unlike previous forms of HRT, BHRT uses hormones that are structurally the same as hormones found in the body (bioidentical).
Many women who start BHRT report drastic improvement in their symptoms, energy, and overall quality of life.
BHRT to Treat Menopause and Perimenopause with Defy Medical
Menopause doesn’t have to mean suffering in silence.
Defy Medical’s BHRT treatment offers women a personalized, science-based approach to managing the symptoms that can disrupt sleep, intimacy, energy, and overall well-being.
Our experienced medical team works directly with you to develop a customized treatment plan based on comprehensive lab testing and your unique symptoms. Whether you’re experiencing hot flashes, night sweats, mood changes, weight gain, low libido, or brain fog, BHRT can help restore the hormonal balance your body needs to thrive.
With convenient telemedicine consultations and medications delivered directly to your door, Defy Medical makes expert BHRT accessible no matter where you live.
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