The U.S. Food and Drug Administration (FDA) health officials warned about "bio-identical hormone replacement therapy" (BHRT) drugs, an increasing popular alternative therapy among women with menopausal symptoms.

The U.S. Food and Drug Administration (FDA) has sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency.  US FDA is concerned that unfounded claims like these mislead women and health care professionals.

According to USFDA press release, 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 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 seven pharmacies are Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed's Compounding Pharmacy of Tucson, Ariz.; and Pacifica Pharmacy of Torrance, Calif.

The FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

FDA also responded today to a citizen petition from Wyeth, Madison, NJ, asking FDA to take regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs.  Other stakeholders, including health care providers and consumer groups, have also raised concerns about "BHRT" drugs.

All patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their health care provider to determine if compounded drugs are the best option for their specific medical needs.