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Editorial JUNE
2009
Are Your Patients Asking for Bioidentical Hormones?
Ronald T. Burkman, MD
The lay media has created a lot of commotion
about “bioidentical” hormones, touting them as
a “safer alternative” to “conventional” hormone therapy (HT), and proclaiming that bio-identical hormones can only be obtained from compounding pharmacies. Television shows, the Web, radio, and consumer books and magazines are sending a dangerous message that
HT produced by pharmaceutical companies and approved by the FDA is unsafe, and that women should use individualized HT developed by compounding pharmacies. Women are apparently doing this in droves, aided by prescriptions being written
by clinicians.
It is unclear, however, why clinicians would support this disturbing trend, especially in light of ACOG’s 2005 committee opinion on compounded bioidentical hormones.1 This statement says:
“…hormone therapy does not belong to a class of drugs with
an indication for individualized dosing. Individualized dosing is indicated when a narrow therapeutic window exists for a drug or a drug class. Such drugs include those with nonlinear pharmacokinetics, those that
are readily eliminated as the active drug, some that are not metabolized during first pass through the liver, and those
with clearly defined therapeutic and toxic concentrations based on large population pharmacokinetics studies of serum concentrations. Steroid hormones such as estrogen and progesterone
do not meet these criteria and, thus, do not require individualized dosing.”
In addition to hormones not qualifying as a drug that requires special treatment with compounding, there is the consideration that compounding pharmacies are not overseen
by the FDA—the states oversee them. This means there is a
wide variation in quality oversight, since state laws and vigilance vary.
On top of all this, there are a huge variety of FDA-approved
HT products available from
regular pharmacies. And those with transdermal routes of administration are even the
so-called “bioidentical” type. Bioidentical is not a medical term, it is only a marketing term, but it is generally accepted to mean a hormone that is chemically identical to the hormone produced in the body (in women, mainly in the ovaries) during women’s reproductive years. By that definition, there are many FDA-approved bioidentical products available!
Many clinicians who acknowledge the WHI was flawed have stopped prescribing HT altogether, and have advised their patients to stop taking it. This is despite ACOG’s continued support of the position that clinicians use HT only for symptomatic women in the lowest possible doses for a short, yet to be defined, period of time. For clinicians concerned about oral medications, particularly those used in the WHI, there are other oral formulations as well as transdermal HT. Potential advantages of transdermal HT over oral HT, which may be a consideration for some clinicians, include less initial hepatic involvement and relatively constant levels of hormones, as opposed to the peaks and troughs seen with oral medications. Transdermal products are also made from soy and other “natural” ingredients and can be considered “bioidentical.” However, it is important to recognize that all of these medications, whether oral or transdermal, are chemically processed.
Finally, most FDA-approved bioidentical HT products are covered under major health plans, can be obtained at regular drugstores, and cost less than compounded HT.
Why not ask your patients
if they are currently taking a compounded HT drug, and
discuss the possible FDA-approved options for them?
If your patients ask for a prescription for bioidentical compounded HT, explain why using FDA-approved bioidentical products makes more sense.
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Ronald T. Burkman, MD, Editor-in-Chief
REFERENCES
- ACOG Committee on Gynecologic Practice. ACOG Committee Opinion #322: Compounded bioidentical hormones. Obstet Gynecol. 2005;106(5 Pt 1):1139–1140.
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