Bioidentical hormones

Are bioidentical hormones FDA-approved?

FDA has approved drugs containing hormones identical to those women make naturally during their reproductive years, and recommends women use FDA-approved hormone therapies [1]. But many products marketed as bioidentical hormones are compounded drugs, which are not FDA-approved, and FDA says it does not have evidence that compounded bioidentical hormones are safe and effective, or safer or more effective, than FDA-approved hormone therapy [1]. There are no FDA-approved drugs containing estriol [1].

What do ACOG and NASEM say about compounded bioidentical hormones?

A 2023 clinical consensus from ACOG says compounding pharmacies use the phrase bioidentical hormone as a marketing term implying these preparations are more natural, and therefore safer and more effective, than FDA-approved menopausal medications, but says evidence to support those marketing claims is lacking, and that compounded bioidentical therapy should not be prescribed routinely when FDA-approved formulations exist [2]. A 2020 NASEM report notes FDA has approved dozens of hormone therapy products for men and women, including estrogen, progesterone and testosterone, while compounded versions are commonly marketed as bioidentical or natural [3].

What does the safety evidence on compounded bioidentical hormones show?

A 2022 meta-analysis pooled 29 randomized trials covering 1,808 perimenopausal and postmenopausal women taking compounded bioidentical hormone therapy and found no change in endometrial thickness or serious adverse events, but its own authors note that cardiovascular events and breast cancer risk were not studied [4]. Three of its authors, including the first author, were employees of PCCA, a compounding pharmacy supplier [4].