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The Truth About 'Bio-identical' Hormone Therapy
Date:1/30/2009

to the FDA.

"The pharmacist assumes that responsibility and the physician should specify that on the prescription," Liu said. So the bio-identical product may not have exactly the same ingredients as a standard product, he said.

But be leery if a pharmacy claims that such compounded mixtures are safer or more effective than other hormone formulations, the FDA warned. They may not be mixed according to a licensed health-care professional's instructions, the agency said.

"Women should be cognizant that both products have similar potencies, similar biological action and similar side effects," Liu said. "There's no reason to think bio-identicals are superior. There are either anecdotal or testimonial claims that one is better than the other. We're swayed by that as human beings."

Here are some points the FDA says to keep in mind:

  • Approved hormone therapies are available by prescription only.
  • Bio-identicals will have the same risks as the products they're identical to -- namely a heightened risk of breast cancer and serious heart problems. There may be other, as-yet-unknown risks, as well.
  • Beware of claims that bio-identical products can be made based on hormone levels measured from a woman's saliva sample. Hormone levels fluctuate constantly. Saliva tests, which are FDA-approved, aren't specific enough to determine drug dosages.
  • No drug containing the hormone estriol (the weakest of the three estrogens produced by the body) has been approved by the FDA. Only prescribers who have an investigational new drug (IND) application can compound drugs with estriol.
  • In general, when using approved hormone-replacement therapies, the FDA and health-care professionals recommend using the lowest dose possible for the shortest period needed.

More information

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