Compounded medications prepared by pharmacists or physicians have been used extensively throughout history as a mainstay of therapeutics. Over the past half-century – with the increasing focus on evidence based treatment the use of compounded medications substantially decreased. However, in some therapeutic areas, such as menopause, use of compounded medications continues.
The continuation of use of compounded medications represents a challenge to the USFDA because the standard evaluations of benefit and risk are not required.
To gain guidance in this concern the FDA asked the National Academies of Sciences, Engineering and Medicine to form a consensus committee to characterize the clinical utility of compounded bioidentical hormone therapy.
The committee was chaired by Dr. Donald Mattison the Chief Medical Officer of Risk Sciences International and composed of a dozen clinicians and scientists who worked together over the course of 1.5 years to pull the literature on risk-benefit, and clinical utility of compounded bioidentical hormone therapy. The publication can be downloaded here.
The committee concluded (Conclusion 9.1) that there is insufficient evidence to support the overall clinical utility of compounded bioidentical hormone therapy as treatment for menopause and male hypogonadism symptoms.