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Often, women request bioidentical hormone therapy of estrogen, progesterone, and/or testosterone from their healthcare provider. But confusion abounds as to the meaning of the term "bioidentical." Several bioidentical hormone products are available in government-approved, well-tested brands, but typically this term is used for hormone recipes made from a prescription by a compounding pharmacist. Is there risk with these therapies? The practice of hormone testing at menopause and providing custom-tailored hormone mixtures based on those tests has been a subject of great debate.
The FDA announced on January 9 that warning letters have been sent to 7 pharmacy operations, indicating that the claims they make about the safety and effectiveness of their so-called “bioidentical hormone replacement therapy” are unsupported by medical evidence and are considered false and misleading by the agency. Pharmacies may not compound drugs containing estriol without investigational new drug authorization. There is no scientific basis for using saliva testing to adjust hormone levels. Read the full press release, letters, and the FDA’s advice about compounding below.
For further consideration, see The Endocrine Society's Position Statement on bioidentical hormones published October 2006 -- and it's officially endorsed by NAMS.
Prior to its 2006 Annual Meeting, NAMS offered a Postgraduate CME Course, entitled “Understanding the Controversy: Hormone Testing & Bioidentical Hormones." This comprehensive course covered the most current regulatory issues, compounding practices, hormone testing, and more.
The printed 32-page monograph published 3/07 presents the proceedings of the Postgraduate Course. Although written for healthcare professionals, consumers will find this monograph of interest as well. Copies may be obtained from NAMS for a nominal fee.
To learn more on this topic, see the NAMS MenoNote® on bioidentical hormones, written for consumers.
The NAMS 2006 Scientific Program Committee hopes that you will enjoy this material. We believe it is one of the best programs offered by the Society. However, please note that this material represents the individual opinions of the faculty, not necessarily those of NAMS. |