Banner Health Services  

What are bioidentical hormones?

Gema Fernandez, MD  

Gema Fernandez, MD,  is an OB/GYN at Banner Estrella Medical Center. Her office can be reached at (623) 936-1780.

Question: I’ve heard that hormone replacement therapy can help with hot flashes. Everyone’s talking about bioidentical hormones. What exactly are they and are they safe? 

Answer: Hormone replacement therapy has long been steeped in controversy due in part to questions and some misinformation. As a result, some women have turned to bioidentical hormones in a misguided effort to ensure their safety.  

In the past, the only hormone replacement therapy pharmaceuticals available were made from the urine of pregnant horses. Over the years, new hormone therapies were developed and rigorously tested by the Food and Drug Administration for safety and efficacy.

Despite advancements, women remain skeptical about hormone replacement therapy. That skepticism grew when certain aspects of the Women’s Health Initiative study were sensationalized. As a result of negative attention, many women moved away from hormone replacement therapy and put bioidentical hormones into the spotlight.     

“Bioidentical hormones” is a marketing term for products made by compounding pharmacies that are supposed to mimic hormones like estrogen, progesterone and testosterone that a woman’s body produces prior to menopause. Since these manufactured compounds are derived from plants, you may hear them referred to as “natural,” leading many to assume they are safe. However, science has proven repeatedly that “natural” does not necessarily mean “safe.”

Bioidentical hormones, and the claims made about them, are not governed and/or approved by the FDA. In fact, in early 2008, the FDA wrote a letter of warning to several national compounding pharmacies regarding misleading claims that bioidentical hormones can prevent conditions like Alzheimer’s disease and stroke. The FDA also conducted a six-month study on a wide range of compounded products. Thirty-four percent of the products tested failed to meet safety standards and 90 percent failed potency (ingredients are as expected) testing. In sharp contrast, only two percent of FDA-approved drugs failed potency testing.

Another myth about bioidentical hormones? The belief that they are personalized for you based on hormone levels tested by saliva or blood. Since hormone levels vary based on factors like time of day and what a person has eaten, hormones created using these inconsistent and unreliable measurement tools cannot possibly guarantee effectiveness. Also, because bioidentical hormones have not been the subject of large-scale medical research, they are unproven science.

If severe hot flashes interfere with your life, do your own homework and discuss options with a physician who is board-certified in women’s health.

Page Last Modified: 02/22/2010
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