With so much confusion surrounding the use of custom-compounded bioidentical hormone therapy for treatment of menopause-related symptoms such as hot flashes, the US Food and Drug Administration (FDA) stepped in with a warning about the potential harm from these products. On January 9, 2008, the FDA warned seven compounding pharmacies that their claims that their drugs can prevent or treat serious diseases, including Alzheimer’s disease, stroke, and various forms of cancer, are unsupported by medical evidence and therefore considered false. Since compounded drugs are not reviewed by the FDA, women are encouraged to use government-approved, tested drugs whenever possible.
The term “bioidentical hormone therapy” itself most accurately describes 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 well-tested, FDA-approved, brand-name prescription drugs.
But concern arises when bioidentical hormones are “custom-compounded” (custom-mixed) from recipes prepared by a pharmacist 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.
• The recipe not only contains the active hormone (or hormones), but also other ingredients that either hold everything together (in the case of a rectal suppository, an under-the-tongue tablet, or an under-the-skin pellet) or provide a vehicle for applying the product onto the skin (such as a cream or gel) or into the body (such as a liquid or a nasal spray).
• There is no scientific evidence about the effects of these compounded medications on the body—either good or bad.
Another fly in the bioidentical ointment is that the salivary and blood testing used by custom compounders to “assess” your hormone levels are meaningless for midlife women because our hormone levels vary from day to day and even from hour to hour.
Custom-compounded hormones may provide certain benefits, such as individualized doses and forms, and mixtures of products that are not available commercially. However, without appropriate testing and standardization of the product you’re putting into your body, there is no assurance that the preparation methods will not vary from one pharmacist to another and from one pharmacy to another. Nor is there assurance that patients will receive consistent amounts of medication. Expense is also an issue, as many custom-compounded preparations are viewed as experimental drugs and are not covered by insurance plans.
Follow these steps before choosing a product for symptom relief:
1. Rely on scientifically proven medications
2. Question deceptive claims of long life and fast relief
3. Talk to your healthcare provider before making any decisions about a nonregulated medication.
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