A NAMS-conducted survey of 3,700 US women aged 40 to 84 years found that about a third of those who use hormone therapy (HT) at menopause are using compounded hormones. There is a common and mistaken belief that compounded hormones are safer and offer more benefits than FDA-approved therapies.
Concerns over health risks have prompted many women who want to take hormones to seek out practitioners who prescribe compounded hormones, which are marketed as natural or bioidentical and therefore perceived as safer than FDA-approved hormones. The so-called bioidentical hormones are plant-derived and chemically similar to those produced by the body. These hormones include commercially available products approved by FDA along with compounded preparations that are not regulated by FDA. The phrase bioidentical hormone therapy has been recognized by FDA as a marketing term and not one based on scientific evidence.
Compounded hormones are custom made by a compounding pharmacist from a healthcare provider’s prescription and specifications, unlike FDA-approved drugs that are manufactured and sold in standardized dosages. Compounded drugs lack an FDA finding of safety, efficacy, and manufacturing quality. Prescribing patterns about compounded hormones are difficult to obtain because prescriptions of compounded hormones aren’t tracked the way those for FDA-approved drugs are.
Adverse effects of hormone therapy were not common among the survey respondents, but the women who used compounded HT reported higher rates of vaginal bleeding and acne than women who used FDA-approved hormones, and four women who used compounded hormones reported that they had endometrial cancer (cancer of the uterine lining), whereas none who used FDA-approved hormones reported a case.
The survey was supported by a grant from TherapeuticsMD, and the survey results were published online inMenopause.