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
"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
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
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
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]