Before we get into this…if you haven’t read my blog post Hormone therapy: how did we get here?, check that out first. TLDR – the hormones taken by women enrolled in the Women’s Health Initiative were predominantly oral (pills) synthetic hormones. The headlines that came out of it basically said hormones are bad. We now know better.
Enter the bioidentical hormone era. After the WHI instilled fear in women, bioidentical hormones were presented as a safer option. Let’s be clear about this - bioidentical is a made up marketing term (not a medical or pharmaceutical term) to make people think that these hormones are safer.
When people talk about “bioidentical” hormones, they are typically referring to compounded medications (medications that are made in a compounding pharmacy that are not tested or regulated). These compounded products are not FDA-approved or regulated, lack standardized dosing, and have not undergone review for safety or effectiveness. That doesn’t mean all compounded meds are bad. They have their place at times. It’s important that your clinician uses a trusted compounding pharmacy when prescribing them.
Let’s take a common example: Biest. It’s a compounded cream that mixes two forms of estrogen: estradiol (the main estrogen your ovaries made before menopause) and estriol (a weaker form mostly made by the placenta during pregnancy). Some claim it’s “safer” because estriol is weaker, but there is no basis to support this.
FDA-approved estradiol, which is chemically identical to what your body makes, became available as patches in the late 1990s and later as gels and sprays. These were not part of the WHI study because they were not on the market until after the study had started. These are what I like to call biosimilar forms: FDA-regulated, effective, and safe. They just need a better PR team to spread the word about their safety and benefits (should I apply for that job?).
So, to clear things up:
- Some FDA-approved hormone products are bioidentical (chemically identical to what your body makes).
- Not all “bioidentical” products are FDA-approved or safe — specifically compounded versions.
Bottom line:
If you’re considering hormone therapy, opt for FDA-approved options and work with a clinician who understands the nuances of prescribing hormones. When hormones are prescribed thoughtfully, can be safe, effective, and life-changing.