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Oprah and Bioidentical Hormones: FAQ

Oprah Is Talking About Bioidentical Hormones for Menopause; Experts Weigh In
By
WebMD Health News
Reviewed by Louise Chang, MD

Jan. 15, 2009 -- Oprah Winfrey says menopause caught her "off guard" and that she's taking bioidentical hormones that have made a big improvement in how she feels.

Bioidentical hormones are one form of therapy for menopausal symptoms. Winfrey, who turns 55 this month, writes in February's edition of O, The Oprah Magazine that she felt "out of kilter" and had "issues" for two years that she suspected were hormonal. Upon a friend's recommendation, Winfrey went to a doctor who specializes in hormones.

Winfrey writes that the hormone specialist told her that her "hormonal tank was empty" and gave her a prescription for bioidentical estrogen.

"After one day on bioidentical estrogen, I felt the veil lift," Winfrey writes. "After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step."

Winfrey isn't recommending bioidentical hormones for every menopausal woman. Instead, she urges women to "take charge of your health" and says it's time to "start the conversation" about menopause and bioidentical hormones.

Oprah writes that bioidentical hormone therapy is controversial and confusing to many people.

What's the controversy about? Are bioidentical hormones better or safer than other hormone therapy? WebMD has answers from experts.

What Are Bioidentical Hormones?

"There is enormous confusion about the meaning of the term 'bioidentical,'" JoAnn Manson, MD, DrPH, tells WebMD via email.

"Bioidentical hormone preparations are medications that contain hormones that are an exact chemical match to those made naturally by humans," says Manson, who is chief of preventive medicine at Brigham and Women's Hospital in Boston and the Elizabeth F. Brigham Professor of Women's Health at Harvard Medical School.

Some bioidentical hormones are made by drug companies, are approved by the FDA, and are sold in standard doses. Other bioidentical hormone preparations are made at special pharmacies called compounding pharmacies, which make the preparations on a case-by-case basis for each patient. Those "custom-made" preparations aren't approved by the FDA.

 

Why Aren't Compounded Bioidentical Hormones FDA approved?

The FDA doesn't approve any compounded products, for any condition, because those products aren't standardized.

That doesn't mean that compounding is bad. Compounding can be useful for patients who are allergic to an additive in an FDA-approved product, says Kathleen Uhl, MD, the FDA's assistant commissioner for women's health.

But "the purpose of compounding is to do it on a patient-by-patient basis, so there's nothing that's submitted to FDA to evaluate, so they're not FDA approved," Uhl explains.

And because compounded products don't go through the FDA approval process, they don't bear the same warnings as other hormone therapy.

A woman who gets a prescription for an FDA-approved hormone therapy for menopausal symptoms is "going to get a lot of warning information," but if she gets a compounded product instead, "you don't get any of those warnings," Uhl says. "There's no requirement for them to provide that because those products are not FDA approved."

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