Custom Hormone Treatments Get Warning

January 2008

The Food and Drug Administration (FDA) ordered seven pharmacies, including one Pittsburgh, Pennsylvania establishment, to stop making “misleading” claims about custom-mixed hormone treatments for menopausal women. The FDA says that the claims have no scientific backing and that tailor-made hormone therapies pose the same health risks as commercially prepared hormone therapies.

The pharmacies claim that the hormone mixes, called “bioidentical hormone replacement therapy,” are safer than prescription estrogen therapy for the treatment of menopausal symptoms. Some also stated that the products can prevent or treat diseases such as Alzheimer’s, stroke and some cancers. The FDA asserts that there is no credible evidence to support any of these claims and that some mixes contain estriol, which is not FDA-approved.

It is estimated that thousands of pharmacies across the nation custom-mix bioidentical hormones. Warning letters were sent regarding the hormones’ safety and performance claims to seven pharmacies including Murray Avenue Apothecary of Pittsburgh, PA.