For years, many women were discouraged from using hormone replacement therapy (HRT) because of the FDA’s “black box” warning—the strongest caution placed on a prescription medication. That warning stemmed from early-2000s research that suggested an increased risk of breast cancer and cardiovascular problems in women taking certain types of hormone therapy.
This month, after a new and extensive review of scientific data, the FDA officially removed the black box warning from menopause-related HRT products. For millions of women seeking relief from life-disrupting symptoms, this decision represents a major shift in how menopause care is understood and delivered.
Watch this recent news update explaining the FDA’s removal of the black box warning on menopause hormone therapy. The story outlines how new evidence is reshaping the conversation around HRT safety.
The original studies that prompted the warning painted a single, sweeping picture of HRT risk—one that experts now agree was oversimplified and, in some cases, misleading. Updated research shows that when HRT is appropriately dosed and started near the onset of menopause (typically before age 60 or within ten years of the last menstrual cycle), the risks are far lower than once believed.
Modern studies have revealed:
With today’s data, the FDA acknowledges that the black box warning unintentionally discouraged patients from seeking care—even when HRT could have been safely and effectively used.
Removing the black box warning doesn’t mean HRT is risk-free, but it does remove a major barrier that prevents open, informed conversations between women and their healthcare providers.
For women experiencing symptoms such as hot flashes, mood changes, fatigue, sleep disturbances, weight gain, or decreased libido, this update encourages a more individualized approach—one that focuses on personal medical history, symptom severity, and treatment preferences.
The federal health department even emphasized that this change marks a long-overdue shift toward taking women’s health concerns seriously.
At The Bariatric Experts™, we’ve long understood that hormone imbalance is more than an inconvenience—it can reshape how you feel every day. Our Bioidentical Hormone Replacement Therapy (BHRT) program, featuring Biote pellet therapy, is designed to restore hormonal balance with precision-dosed, naturally derived hormones.
Many women begin experiencing symptoms of hormone decline years before traditional menopause. Because BHRT is tailored to each patient’s levels, it can be used to address:
The FDA’s updated guidance reinforces what clinicians and researchers have observed for years: when customized and monitored properly, hormone therapy can be both safe and transformative.
Even with the removal of the black box warning, thoughtful evaluation remains key. Women considering HRT should discuss:
These conversations help determine whether BHRT—including long-acting Biote pellets—may be a good fit for your goals and health profile.
Our team takes a comprehensive approach to diagnosing hormone imbalance, beginning with detailed lab testing and a careful review of your symptoms. If Biote pellet therapy is appropriate, we build a plan that fits your metabolism, lifestyle, and long-term health goals.
From the quick in-office pellet insertion procedure to ongoing monitoring, we’re committed to helping our patients in Frisco and the greater DFW area feel like themselves again.
The FDA’s updated stance is an important step toward accurate, supportive menopause care. If you’ve been hesitant to explore hormone therapy—or were advised against it years ago—now is an ideal moment to revisit the conversation with a provider who specializes in hormonal health.
The Bariatric Experts™ is here to help you understand your options and find a path that supports your healthiest, happiest life. Contact us to schedule your consultation with a trusted provider.
