This long-awaited news is in. The United States Food & Drug Administration (FDA) has officially announced that it will be removing its black box warnings from most hormone replacement therapies (HRT) for menopause.
A black box warning indicates serious or potentially fatal side effects and is the most severe warning the FDA can apply to a prescription medication. Thes black box warning has been included on HRT products since 2003.
According to the FDA, the decision to remove the black box warnings followed an extensive review of scientific literature, as well as input from an expert panel in July.
Before 2003, hormone replacement therapy had been widely prescribed for decades. HRT use saw huge declines after a 2002 Women's Health Initiative study found it could raise the risk of strokes, breast and ovarian cancers, dementia, and other serious conditions, prompting the black box warning.
After years of clinical research since then, there is clear consensus now on the benefits of HRT, especially for women starting therapy early in menopause.
The FDA is asking pharmaceutical companies to update their labels as they exist currently on HRT products, removing risks for dementia, breast cancer and cardiovascular disease and instead reflecting the updated science that shows the benefits of HRT.
Drugmakers are also being asked to include the FDA’s recommendation that women begin HRT within 10 years of the start of menopause or before age 60, while most women still maintain estrogen receptors in their bodies. The average age of onset for menopause is 51.
Hormone replacement therapy for women includes prescription estrogen, progesterone, and sometimes testosterone therapy prescribed for women in menopause to replace the hormones that begin to rapidly decline in this stage of life.
An array of life-disrupting symptoms often accompany a woman’s transition into menopause. Ranging from hot flashes and mood swings to sleep problems, decreased libido, vaginal dryness, thinning hair, weight gain, cognitive issues and others, menopause symptoms have typically been treated with HRT, lifestyle changes, alternative therapies or other medication.
Unfortunately, in far too many cases, they are not treated at all, and millions of women suffer needlessly. Currently, over 1 billion women worldwide are in perimenopause, menopause, or postmenopause. Because women are living longer, projections indicate it will top 1.2 billion by 2030.
HRT can effectively treat these symptoms, and it also can also have a hugely protective benefit for cardiovascular risk and bone loss as well as cognitive decline in women as they enter menopause.
The recent removal of the black box warnings on HRT – announced on November 10, 2025 – has been welcomed by the National Menopause Foundation. Many longtime proponents of hormone replacement therapy, including Dr. Rubin, have praised the move.
The black box warnings – based on those older studies - were not only misleading for many women but deterred doctors from prescribing HRT. Even with the warnings removed, hat stigma still exists and it is crucial to educate doctors who may still be hesitant to prescribe hormone replacement therapy for women.
Dr. Rubin has always been a strong proponent of HRT for women, understanding that conditions like perimenopause, menopause and other conditions that create hormone imbalances in women can be safely addressed. Alleviating symptoms like hot flashes, mood changes, weight gain and diminished sex drive – once considered a natural consequence of aging – is a clear medical responsibility for a woman’s overall health and wellbeing.
The decline in sex hormones like estrogen, progesterone, DHEA and testosterone can be relieved through life-changing hormone replacement therapy.
Here at our clinics in Tampa and Naples, Florida, we recommend Bioidentical Hormone Replacement Therapy. It’s just one more effective tool is our toolkit to optimize both male and female health and sexuality.
To embark on a personalized functional medicine journey into the natural, healthy function your body was designed to enjoy, call either of our offices or book online today:
Hormones are chemicals created by your endocrine glands and function as messengers that direct certain systems and functions in your body. When those hormones decline, various bodily functions – not just sexual function – can begin to create symptoms.
Bioidentical hormone replacement therapy (BHRT) involves introducing bioidentical hormones into the body to correct any hormonal imbalances that you are experiencing. BHRT stabilizes hormonal imbalance, restoring normal function.
Bioidentical hormones are made from plant estrogens that are chemically identical to the hormones that your body naturally produces. Designed to be molecularly identical and mimic the effect of hormones produced by your body, these hormones are made from plants like yams, flax, and soybeans, and can be easily customized to fit your specific needs – without the side effects of synthetic hormones.
BHRT is a natural alternative with minimal side effects compared to traditional hormonal replacement therapies that introduce synthetic hormones into the body. Unlike bioidentical hormones which can be precisely formulated for each patient’s individual needs, synthetic hormones are patented and cannot be customized from patient to patient.
Some bioidentical hormones are premade by drug companies, while others are custom-made by a pharmacist, or compounded, based on your physician’s prescription. BHRT hormones come in various doses and forms, including:
Some individuals begin to experience mild relief within a few weeks, but usually, it takes up to three months to appreciate the full effects of hormone therapy.
Both women and men experience the benefits of BHRT, including:
Dr. Rubin is a widely respected functional medicine practitioner in Florida with offices in Naples and Tampa. He has extensive experience in men’s health and treating patients who are struggling with hormonal and sexual health issues.
An Advanced Fellow in the American Academy of Anti-Aging Medicine, AMA Board Certified in Internal Medicine and Geriatrics Medicine, Dr. Rubin is a dedicated medical professional with an exceptional track record. He spent the first 25 years of his medical career working in internal and geriatric medicine, successfully becoming one of Palm Beach County’s top-rated physicians. For four years, Castle Connolly Medical, Ltd. recognized him as one of the “Top Doctors” in South Florida.
After further specialized training, he shifted his practice to a functional medicine approach to better serve the needs of his patients. Over the last 15 years, Dr. Rubin has honed his focus creating a practice rooted in evidence-based healthcare that addresses the root causes of your symptoms.
Combining this with his expertise in Internal Medicine and Geriatrics, he provides a comprehensive approach to your health. Listening attentively to your concerns, Dr. Rubin personalizes a treatment protocol to meet your needs, guiding you confidently on your journey into hormonal and sexual health – at any age.
Dr. Rubin takes an individualized approach to treatment, recognizing that each patient has a different medical history, symptoms, and underlying issues.
Contact us today at either of our two locations to begin your journey into full health and sexual function with a personal consultation to explore Bioidentical Hormone Replacement Therapy for hormone decline or imbalance. You can also learn more about our convenient telemedicine options for all of your health needs in Palm Beach, Broward and across the state of Florida!
