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Amidst the confusion surrounding the use of custom-compounded bioidentical hormone therapy for treatment of menopause-related symptoms such as hot flashes, The North American Menopause Society (NAMS) confirms its support of the US Food and Drug Administration (FDA) and other scientific organizations that have warned women about the potential harm from these products.
The term “bioidentical hormone therapy” is often used to describe a medication containing estrogen, progesterone, or other hormones that are chemically exact duplicates of hormones produced by women, primarily in the ovaries. Many of these bioidentical hormones (eg, estradiol, progesterone) are commercially available in several well-tested, FDA-approved, brand-name prescription drugs. A list of government-approved bioidentical hormone therapy products in the United States and Canada is posted on this site.
Concern arises with the bioidentical hormone medications that are “custom-compounded” (custom-mixed) recipes prepared by a pharmacist following an individual prescriber’s order for a specific patient. These medications do not have FDA approval because individually mixed recipes have not been tested to prove that the active ingredients are absorbed appropriately or provide predictable levels in blood and tissue. Further, there is no scientific evidence about the effects of these compounded medications on the body—both good and bad.
Salivary and blood testing of hormone levels used by custom compounders is meaningless for midlife women as their hormone levels vary throughout the day, and from day to day.
NAMS has much more information about Bioidentical Hormone Therapy. Follow the links below.
- What Is Custom-Compounded Therapy?
Custom-compounded hormones may provide certain benefits...but there may be risks to the
consumer, too.
- What Is Hormone Testing?
Menopausal hormone levels vary throughout the day, as well as from day to day. NAMS does not recommend hormone level testing.
- 2008 9-page transcript of a talk (with slides) by Bruce Patsner, MD, JD, entitled “Bioidentical Hormone Therapy: What’s the Harm?”
There has been a clear lack of medical evidence supporting either the efficacy or safety claims of “individualized” prescription drugs.
- 2006 Postgraduate Course monograph on bioidentical hormones.
“Understanding the Controversy: Hormone Testing & Bioidentical Hormones" was a comprehensive course presented by experts in the field.
- The Endocrine Society’s Position Statement, which NAMS endorsed
As a result of unfounded but highly publicized claims, patients have received incomplete or incorrect information regarding the relative safety and efficacy of hormone preparations that are referred to as “bioidentical.”
- FDA Takes Action
“The pharmacy operations improperly claim that their drugs...are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.”
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