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Compounded Hormone Therapy Drug-makers Warned

Quality Digest
Tue, 01/22/2008 - 22:00
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(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration has sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of so-called bio-identical hormone replacement therapy (BHRT) products are unsupported by medical evidence, and are considered false and misleading by the agency. The FDA is concerned that unfounded claims like these mislead women and health care professionals.

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 hasn’t 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.

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