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FDA Targets Makers of 'Bio-Identical' Hormones

Companies have made unfounded claims regarding the safety and efficacy of these products

THURSDAY, Jan. 10 (HealthDay News) -- The U.S. Food and Drug Administration sent official warnings this week to seven pharmacy manufacturers producing "bio-identical hormone replacement therapy" (BHRT) products, stating the companies are in violation of federal law by making false and misleading claims about the efficacy and safety of these drugs.

The companies have claimed that the BHRT products, which contain hormones such as estrogen, progesterone and estriol, are superior to FDA-approved hormone replacement therapies and can prevent or treat diseases such as Alzheimer's disease, stroke and various cancers. However, these claims are not supported by medical evidence and thus are considered false by the FDA.

In addition, the FDA warned the companies about the use of term "bio-identical" to improperly imply that the marketed drugs are natural or identical to hormones made by the body, for which there is no medical or scientific basis. Companies that do not address the violations detailed in the warning letters face further injunctions including potential seizure of drugs.

"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Janet Woodcock, M.D., FDA's chief medical officer. "In addition to today's regulatory action, FDA is publishing an informational article for women on its consumer health information Web page that provides the facts to make informed decisions about these unapproved therapies."

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