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.
More RSI News
The Society for Risk Analysis (SRA) Council has awarded Dr. Hartnett the 2016 Chauncey Starr Distinguished Young Risk Analyst Award. The Chauncey Starr Distinguished Young…Read News Item
Because there is limited information available concerning the use of psychiatric drugs among the US adult population, Drs Moore and Mattison sought to characterize adult…Read News Item
Following up on the recommendations put forth by the Expert Management Panel on River Flood Mitigation, the Environmental and Safety Management (ESM) and Water Resources (WS)…Read News Item