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FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading

Bridget M. Kuehn
JAMA. 2008;299(5):512. doi:10.1001/jama.299.5.512.
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The Food and Drug Administration (FDA) is warning physicians and consumers about false and misleading claims being made by some compounding pharmacies that are marketing so-called bio-identical hormone replacement therapy (BHRT) products. The agency also has sent warning letters to 7 such pharmacies; the warnings order the pharmacies to stop making these false or misleading claims and threaten further regulatory action if they do not comply.

Among the false or misleading claims the agency takes issue with are the description of these products as “bio-identical,” implying that these products are natural or identical to hormones made by the body. Additionally, the agency has warned the pharmacies to stop making unsupported claims. Such claims assert that these BHRT products are safer or more effective than FDA-approved hormone therapies and that they can treat or prevent conditions such as Alzheimer disease, stroke, heart disease, or cancers. The action was spurred by a petition from Wyeth in Madison, NJ, and physicians and consumer complaints.



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