Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Statement on Compounded Bioidentical Hormones
J Clin Endocrinol Metab; ePub 2016 Apr 1; Santoro, et al
A scientific statement from the Endocrine Society finds that there is no rationale for routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical hormone therapies.
The statement reviews estradiol and estrogens, progesterone and progestins, testosterone, dehydroepiandrosterone, levothyroxine, and triiodothyronine. The authors note that:
• There is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination.
• There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations.
• With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace “abnormal” hormone deficiencies has no basis in medical practice.
• There is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone.
• No evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with FDA-approved hormone treatments.
Citation: Santoro N, Braunstein G, Butts C, Martin K, McDermott M, Pinkerton J. Compounded bioidentical hormones in endocrinology practice: An Endocrine Society scientific statement. [Published online ahead of print April 1, 2016]. J Clin Endocrinol Metab. doi:http://dx.doi.org/10.1210/jc.2016-1271.
