Oprah and Bioidentical Hormones: FAQ
Oprah Is Talking About Bioidentical Hormones for Menopause; Experts Weigh In
WebMD News Archive
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
"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.