An evolution in menopausal hormone therapy (MHT) is officially underway. New interpretations of safety data from randomized trials and observational studies have resulted in the Food and Drug Administration (FDA)’s decision to remove the class-wide black box warnings for many systemic estrogen and combined estrogen-progestogen (EPT) products, and experts in women’s health are advocating to remove the barriers and improve access to MHT.
Life-Changing Medication
Throughout the human body, hormones support physical, mental, and metabolic health. As hormone levels decline with age, the risk of arthritis, heart disease, cancer, diabetes, and other chronic conditions rises, and many women experience the symptoms of menopause and perimenopause, including hot flashes, insomnia, and brain fog. HRT provides women with bioidentical estrogen and sometimes progesterone, but a controversial Women’s Health Initiative study in 2002 suggested that the therapies raise the risk of breast cancer, putting an end to HRT’s widespread use in the U.S.
Mindy Goldman, MD,OB/GYN, chief clinical officer at Midi Health, said that the study “impacted people’s ability to get a really life-changing medication.
“Because the risks at that time were felt to be greater than the benefits, the fallout from that was to tell women, just deal with the symptoms — that they will get better with time.”
Now, more than two decades later, that narrative has changed.
“Controlled Substance”
The FDA’s removal of broad “black box” warnings from HRT products for menopause is the culmination of several factors, including a comprehensive review of the scientific literature and an acknowledgement of the expert panel’s findings. It reflects a growing understanding among women’s health experts that treating menopause, whether hormonally or otherwise, improves quality of life and may stave off many conditions associated with aging in women, such as heart disease, osteoporosis, and cognitive decline.
The risks HRT may pose are far from uniform, varying by patient factors, delivery method, and formulation, and new therapies have been developed that balance symptom relief with long-term safety.
Now, as the agency works to update language in product labeling, clinicians are focused on removing barriers to the use of testosterone in MHT. Currently labeled a controlled substance, Mohit Khera, MD, MBA, MPH, A4M faculty member and professor of urology at Baylor College of Medicine and Abraham Morgentaler, MD, the Blavatnik Faculty Fellow in Health and Longevity at Harvard Medical School went to the FDA in December as part of an expert panel discussing various issues in testosterone replacement therapy, including efficacy, safety, and necessary changes to the product label.
“We give patients human chorionic gonadotropin, which raises testosterone,” said Dr. Khera. “We give patients clomiphene, which raises testosterone. We use other medications that raise testosterone, and none of these are considered controlled substances, but they do the exact same thing. They’re raising testosterone.”
Dr. Morgentaler noted the importance of FDA labeling, citing the agency as the closest thing the medical industry has to a centralized, ultimate authority.
“We have guidelines, and we have the societies that tell us what to do, but the FDA is supposed to kind of serve as a neutral arbiter, if you will, of true risks and indications,” he said. “A lot of primary care doctors look to the FDA label to find out what is legitimate and what’s not.”
The Future of Hormone Health
Another place to look for the latest science-based information on HRT is A4M’s Bioidentical Hormone Replacement Therapy (BHRT) Symposium in Las Vegas this February 26-28. The future of hormone health is being charted today, and the BHRT Symposium offers the most current information available on the science and practical skills required to deliver safe, evidence-based BHRT for women and men.
After decades of setbacks and bad information, menopause care is coming into its own, and BHRT covers the emerging therapies that could make menopause a different experience for millennial women than it was for previous generations. That means improving patients’ quality of life by restoring hormones to optimal levels while minimizing side effects and complications, and by learning to integrate hormone health into diverse practices.
As the experts breach the barriers to HRT access, a new world of treatment is opening up for patients and clinicians. Are you ready to be part of it?
SOURCES How Do Experts Perceive Warning Removal for Menopausal HT? The FDA Listened on Estrogen. Will They Now Fix Testosterone’s Outdated Label? Women were denied this ‘life-changing’ menopause treatment for decades. That’s finally changing.