10 Things You Need to Know about Bioidentical Hormones

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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The use of bioidentical hormones by menopausal women is on the rise. Bioidentical hormone replacement, also known as compounded hormone therapy, isn’t nearly as well studied as conventional hormone replacement therapy and isn’t regulated—yet it is used by 2.5 million women in the US.

Why’d they become a thing? After publication of the 2002 Women’s Health Initiative findings there were new fears about conventional FDA approved hormone therapy like Prempro, Premarin, estradiol, Menest, and others. Bioidenticals are viewed as an alternative approach to treating menopause, but you should know what you are getting into.

If you’re thinking about using bioidentical hormones, here are 10 facts you need to know:

  1. Many health insurance companies don’t cover compounded hormone therapy, or reimburse you if you pay out of pocket.
  2. Most users of compounded hormone therapy are not aware that these medications are not FDA-approved.
  3. In one survey, two-thirds of 184 women (67%) believed that compounded hormone therapy was safer than FDA approved conventional hormone therapy, but that has never been shown to be true.
  4. Eek—cancer! There have been cases of endometrial (uterine) cancer noted among users of bioidentical hormones. This underscores the risks associated with using unregulated medications.
  5. The consensus of the medical community is that menopausal candidates for hormone therapy should be aware that FDA-approved bioidentical estradiol and progesterone formulations are available, and they should be discouraged from using unregulated products.
  6. How can people sell unregulated products? In 2001, the US supreme court ruled that pharmacies could market compounded products that were unregulated by the FDA. That’s when compounded hormone therapy became popular.
  7. Though many women consider compounded/bioidentical hormone therapy options to be more ‘‘natural’’ and safer, compounded products are not FDA-approved and are thus not tracked or monitored in the same way. Please know that certain types of bioidentical hormones have been advertised to prevent breast cancer and heart disease, achieve weight loss, or slow the aging process without any real clinical studies to back up these assertions.
  8. Many doctors who sell compounded hormone therapy also recommend checking salivary hormone levels to keep an eye on your treatment. This has been well studied and unfortunately, people are not aware that such levels do not reflect serum (blood) hormone levels. Please don’t waste your money.
  9. In fact, monitoring hormone levels is not routinely recommended in managing the treatment of women using hormones.
  10. An estimated 26 to 33 million compounded hormone therapy prescriptions a year are filled at community and compounding pharmacies, for a revenue of 1 to 2 billion dollars. It’s quite a money making business.

Dr O.

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