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Menopause Health Center

Menopause: Is There Life Beyond Hormone Replacement Therapy?

Post-HRT, what are women doing to manage menopause symptoms? And are compounded bioidenticals safe?
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Are bioidenticals the answer?

You may have heard that Oprah Winfrey’s taking “bioidenticals” for menopause relief. And Suzanne Somers endorses them in her books and on TV. But are they safe?  

Bioidentical hormones are chemically derived from extracts found in yams or soy. For many years, doctors have prescribed clinically tested, FDA-approved, bioidentical hormone drugs, such as pharmaceutically manufactured estrogen patches, pills, creams, and natural progesterone, to ease menopause symptoms.

But these aren’t the products generating the current buzz -- and controversy. In recent years, Somers and other celebrities have promoted these compounded bioidentical hormones as safer, more effective, and more natural than synthetic hormones.

That’s not necessarily the case. Consider:

Bioidenticals aren’t FDA approved. The drugs are mixed to order, so there is no testing of their efficacy or safety. Compounding pharmacies do use some of the same ingredients found in FDA-approved products. However, their compounded bioidentical mixtures are not FDA-approved or regulated. They may even pose potentially serious side effects.

Bioidenticals may have side effects. “Don’t go in thinking these things are totally risk-free and that there’s tons of data,” says Mary Jane Minkin, MD, an obstetrician and gynecologist who fields numerous requests from patients, yet urges them to steer clear of these unregulated drugs. Both doctors express frustration, though, that their warnings are often drowned out by the chorus of endorsements from celebrities and others with no medical training.

Bioidentical doses aren’t regulated. “The doses they’re promoting are much greater than what patients should be taking,” says Michelle Warren, MD, of the Center for Menopause, Hormonal Disorders, and Women’s Health at Columbia University Medical Center. And, because compounded hormones aren’t regulated, they carry no black box warnings, nor are there requirements to report adverse effects to the FDA.

Bioidenticals are chemicals. Many women mistakenly believe that compounded hormones are “all natural” and come straight from plants, but they’re actually chemically manufactured in a lab, Minkin says, and the actual compounded hormone product isn’t FDA-regulated. Experts say there’s no way to vouch for potency, purity, safety, or efficacy.

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