Bioidentical hormone replacement therapy not safe according to FDA

Food and Drug Administration took first steps to stop Internet sales of custom-mixed hormones for menopausal women, considering the estrogen therapy too risky.

Bioidentical hormone replacement therapy is used to help treat the symptoms of menopause, perimenopause, and post-menopause. Treatment with bioidentical hormones usually includes creating a unique cocktail of hormones for the individual patient, based on hormone deficiencies identified via saliva samples. These are often referred to as "custom-compounded" hormone products. The major benefit of this type of treatment is that doses are individualized, and the mixture of products may not be commercially available. However, although the estrogen and/or progestogen components are government approved, the mixtures themselves are not, as they have not been studied to confirm that they are absorbed appropriately or provide predictable levels in blood and tissue.

Bioidentical hormones, sometimes referred to as natural hormones, are those that are molecularly identical to the hormones that are produced in the body. Hormones and steroids are taken from plants and animals and altered to be identical in molecular structure, then put into a form that can be absorbed by the body: cream, oral, suppository or injections. The plants that the hormones are extracted from are soy and yams, while the animals are pigs or horses. Although these hormones become molecularly identical to the ones humans produce, they cannot be considered completely natural due to the fact that they are altered in a laboratory.

The FDA recognizes pharmacy compounding of BHRT products when the product conforms to a licensed practitioner’s decision that an FDA-approved drug does not meet the patient's needs, but the FDA is concerned that some claims about BHRT products may be false or misleading. Some bioidentical hormones are FDA approved.

Individually-compounded mixtures have not been approved by the FDA, and by their very nature are not susceptible to FDA approval. Consequently, they are untested for purity, potency, efficacy or safety, and some may contain unknown contaminants. Bioidentical estrogen and progesterone are available in FDA-approved forms - estradiol derived from soy or yam sources is found in some approved medications.


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