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Oprah and Bioidentical Hormones: FAQ

Oprah Is Talking About Bioidentical Hormones for Menopause; Experts Weigh In

Why Aren't Compounded Bioidentical Hormones FDA approved? continued...

L.D. King, executive director of the International Academy of Compounding Pharmacists, suggests that patients look for accredited compounding pharmacies listed on the web site of the Pharmaceutical Compounding Accreditation Board (PCAB).

"They make sure those accredited pharmacies are adhering to a very high level of practice, which would include pretty extensive quality control," King tells WebMD. He also suggests that because there aren't a lot of PCAB-accredited compounding pharmacies, patients should ask compounding pharmacies what types of quality assurance procedures are in place.

Manson points out that with FDA-approved "bioidentical" drugs available, "most women interested in bioidentical formulations do not need to take custom-compounded products (exceptions would be women with allergies to ingredients, or intolerances to doses, in commercially available products)."

 

Does That Mean Compounded Bioidentical Hormones Are Safer?

"There is no reason to think that these bioidentical compounded [products] would have a different safety profile than the FDA-approved ones," Uhl says. She points out that some compounded pharmacies have gotten warning letters from the FDA for false and misleading claims about safety and other benefits.

Isaac Schiff, MD, chief of obstetrics and gynecology at Massachusetts General Hospital, agrees.

Schiff led an American College of Obstetrics and Gynecology (ACOG) committee that reviewed the scientific evidence on compounded bioidentical hormone therapy in 2005. That committee concluded that there wasn't scientific evidence to support claims of increased efficacy or safety for compounded estrogen or progesterone regimens. The North American Menopause Society (NAMS) and the Endocrine Society have issued similar statements.

"It may be safer, but that study hasn't been done yet," Schiff tells WebMD. He says he would like to see a large, lengthy, rigorously designed study on the topic.

"I'm not inherently negative about it," Schiff says. "I hope they'd be good ... and if it turns out to be safer, fabulous. I would like, as a physician, to prescribe the safest hormones to my patients who want to be treated."

Erika Schwartz, MD, a New York doctor who prescribes FDA-approved biodentical hormones and compounded bioidentical hormones, says there have been studies that support the safety of bioidentical hormones, compared to other hormone therapy.

Schwartz asks, "If NAMS or ACOG says there are not enough studies, well, why haven't you done the studies if you think you need more? If this had been men's health, would we be having this conversation, or would we have answers?"

Schwartz says she has long wanted to see large, government-sponsored studies compare bioidentical and other hormone therapies head to head.

"She's allowed to have her opinions," Uhl says. "The evidence that FDA has seen and what's available in the medical literature leads us to believe that there are the same concerns" with bioidentical and other hormone therapy for menopausal symptoms.

Uhl adds that "the FDA is not prohibiting the compounding of bioidentical hormones. There is definitely a niche for them and certain patients do need this, but it's not for everybody, and the people who are taking it need to realize that the risks are probably the same for the FDA-approved drugs as they are for the [compounded] bioidentical."

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