FDA warning on 'bio-identical' HT

April 1, 2008

Certain claims about the safety and efficacy of bio-identical hormone therapy (BHT) are unsupported by medical evidence, says the Food and Drug Administration in a January 9, 2008 statement.

Certain claims about the safety and efficacy of bio-identical hormone therapy (BHT) are unsupported by medical evidence, says the Food and Drug Administration in a January 9, 2008 statement.

The FDA says that "the pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and which has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer."

The FDA sent warning letters to the pharmacy operations in question advising that they are violating federal law by making false and misleading statements. In addition, FDA published an informational article for women on its consumer web page so that they can make an informed decision with their physicians about these unapproved therapies. For more information, see http://www.fda.gov/cder/pharmcomp/default.htm.