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U.S. Department of Health and Human Services

Safety

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Compounded Menopause Hormone Therapy Drugs

Audience: Healthcare Professionals, patients

[Posted 01/10/2008] FDA informed healthcare professionals and patients that the Agency 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. 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 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. 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 healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness.

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

[January 09, 2008 - News Release - FDA]