The claims that compounded bioidentical hormones are superior to conventional menopausal hormone therapy are unsupported by evidence, according to a new committee review of compounded bioidentical menopausal hormone therapy.1 Furthermore, these superiority claims pose additional risks to consumers because the ingredients are of variable purity and potency and because efficacy and safety data are lacking.
Short-term use of FDA-approved, commercially available menopausal hormone therapy, such as micronized progesterone(Drug information on progesterone) and estradiol(Drug information on estradiol), is highly effective and associated with fewer adverse effects in younger women with symptoms of menopause.2 The safety and efficacy profiles of compounded hormones, however, are unknown and should only be used with extreme caution when a commercially available product is unavailable.
Traditionally, compounding was a means to make a medication available to a patient who otherwise could not take it because of an offending ingredient (eg, eliminating peanut oil in progesterone for a patient with a peanut allergy). The practice of blending commercially available drug products in proportions tailored to an individual patient’s needs is a nontraditional use of the practice.
The problem with compounded hormones, such as biestrogen, triestrogen, dehydroepiandrosterone, pregnenolone, testosterone, and progesterone, is that they are not regulated by the FDA. Pharmacies often claim that the hormones used in compounded preparations are bioidentical—plant-derived hormones that are chemically similar or structurally identical to those produced by the body. However, the term “bioidentical” has become marketing jargon and labeling a product as such does not mean that there is bioavailability or that scientific evidence supports the claim of effectiveness for the condition being treated.
There have also been assertions that compounded bioidentical menopausal hormone therapy can be custom blended based on the results of salivary hormone level testing. However, there is no meaningful evidence that supports use of this practice. Individualized salivary, serum, or urinary testing is only needed when there is a narrow therapeutic window for a drug, and steroid hormones do not meet this criterion.
In general, compounded products are inferior to FDA-approved medications. Compounding introduces multiple sources for adverse drug effects, and the lack of regulation allows for their dispensation to occur without product labeling, including information about contraindications and black box warnings.
- Menopausal hormonal therapies with FDA approval are safer and more effective than individual pharmacy-compounded preparations.
- Most compounded preparations have not been tested for safety or efficacy, and the purity, potency, and quality of these preparations are questionable.
- Variable bioavailability and bioactivity in compounded products makes possible both underdosage and overdosage.