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

, many 'bioidentical hormone' formulations are not subject to FDA oversight and can be inconsistent in dose and purity."

Since the release in 2002 of a Women's Health Initiative report, hormone replacement therapy (HRT) -- used to relieve symptoms of menopause -- has generated worrisome, and sometimes conflicting, headlines. While linked to a reduced risk of colon cancer and fractures, the therapy has also been associated with an increased risk of breast cancer, stroke, blood clots and heart attack. And -- so far, at least -- there are no indications that HRT has any effect on the development of dementia.

The not-inconsiderable list of potential risks of hormone-replacement therapy has left an opening for manufacturers of "natural products" to step up with supposedly better and safer versions of hormone therapy, according to the FDA.

Marketers of bio-identical hormones often say the products are identical to hormones produced by the body, and these "all-natural" pills, creams, lotions, and gels don't carry the risks of menopausal hormone therapies approved by the FDA. Agency-approved HRT drugs are typically prescribed to treat symptoms of menopause, such as hot flashes and vaginal dryness.

But the FDA said it hasn't approved compounded "BHRT" drugs and can't assure their safety or effectiveness.

Liu said that " 'bio-identical' really means that the structure of the compound you're claiming to be identical is biologically identical. It [the term] is applied primarily to female hormones that are used in hormone therapy."

But, Liu added, "the main problem is how a woman would obtain [bio-identicals]. If it's pharmaceutical grade, FDA-grade, it's prescribed. It's just how it's made."

Some of the bio-identical hormones are "compounded," meaning they are mixed specially to meet an individual's needs. For example, some dyes or preservatives may be eliminated if a person is allergic to them, according
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