Oprah and Bioidentical Hormones: FAQ
Oprah Is Talking About Bioidentical Hormones for Menopause; Experts Weigh In
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Why Aren't Compounded Bioidentical Hormones FDA approved? continued...
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."
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.