The Medical Letter on Drugs and Therapeutics
Bioidentical Hormones
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In recent years, many women have become concerned about the safety of pharmaceutical replacement hormones for treatment of menopausal symptoms. “Bioidentical” hormone preparations, which are not approved by the FDA, are heavily promoted in popular books and on TV as alternatives; these are derivatives of soy or plant extracts, chemically modified to be structurally identical to endogenous hormones. Most FDA-approved single-entity hormones are also derivatives of soy or plant extracts and are structurally identical to hormones produced by the ovary.1

MANUFACTURING STANDARDS — Bioidentical hormones are generally prepared in compounding pharmacies, which are not regulated by the FDA.2 The FDA has reported sub-potency, super-potency and contamination of pharmacy-compounded drugs. In one 2006 survey, their potency ranged from 67.5% to 268.4% of the amount specified on ... more      

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