Harvard Women's Health Watch

Negotiating the "bio-identicals" controversy

The FDA says some compounding pharmacies have stepped over the line.

In January 2008, the FDA sent letters to seven compounding pharmacies, warning them not to claim that their custom-made hormone therapy products are safer or more effective than conventional hormone therapy or can treat or prevent conditions such as Alzheimer's disease, breast cancer, heart disease, and depression — claims for which there is no scientific proof. The agency also wants compounders to stop using the term "bio-identical," on the grounds that it misleads women and health care professionals by incorrectly suggesting that their mixtures are more "natural" than standard hormone therapy or exactly the same as hormones made by the body. The warning letters also told compounders to discontinue the use of estriol, a weak form of estrogen produced during pregnancy. Estriol is not approved for clinical use, but it has been incorporated in many compounded hormone products (including the popular combinations Biest and Triest).

Unlike conventional FDA-approved hormones, the compounded versions aren't tested for safety, effectiveness, purity, or potency. Though many women regard them as a safe alternative to conventional hormone therapy, there's no proof that "bio-identicals" are any safer. The FDA action reflects the views of the American Medical Association, the Endocrine Society, the American College of Obstetricians and Gynecologists, and the American Academy of Family Practitioners.

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