The main problem with the compounded hormones, as I see it, is that women who use them do not receive any written information from the compounding pharmacist about risks and benefits. Nor do they receive the black box warnings on FDA-approved estrogen therapy. I believe women need to be adequately educated about the potential risks and benefits, as well as the lack of efficacy data and quality control, if compounded products are requested. That means it’s up to the prescriber to educate the patient about the potential risks and benefits.
Rosenthal states that symptomatic menopausal women or those who fear breast cancer or heart disease can be considered a vulnerable population: “Patients do not have the background to decipher credible sources from noncredible sources.” False claims present convincing arguments for laypersons. A woman may be vulnerable to unsubstantiated claims by virtue of her symptoms and the anxiety and even depression that they can produce. Without comprehensive education, these women cannot be assumed to be adequately informed.
Let me put it in perspective. If a patient with a history of breast cancer complains about severe vaginal dryness that interferes with her sex life, I might decide to give her the smallest amount of topical estrogen that I can—for example, a dime-sized amount of estrogen to apply to her vulvar area twice a week. This amount of estrogen can’t be detected in her system with current assays. I know that some of it will be systemically absorbed, but it cannot be detected. When the patient buys that commercially prepared cream from the pharmacist, she will receive the same black box warning that comes with all systemic hormones since the WHI. However, if she goes to a compounding pharmacist with a prescription for bioidentical hormone therapy, she will not get the warning, regardless of the ingredients or dosage.
ACOG, NAMS, and The Endocrine Society agree: Compounded hormones are not safer
The American College of Obstetricians and Gynecologists (ACOG), North American Menopause Society (NAMS), and The Endocrine Society have all issued statements noting the lack of safety data on compounded bioidentical hormones. Here’s what they say:
ACOG
“Most compounded products have not undergone rigorous clinical testing for safety or efficacy, and issues regarding purity, potency and quality are a concern. Compounded hormone products have the same safety issues as those associated with hormone therapy agents that are approved by the US Food and Drug Administration and may have additional risks intrinsic to compounding. There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens.”
NAMS
“NAMS does not recommend custom-compounded products over well-tested, government-approved products for the majority of women—and does not recommend saliva testing to determine hormone levels” (www.menopause.org/bioidentical_NAMS.aspx).
The Endocrine Society
“‘Bioidentical hormones,’ particularly estrogen and progesterone, have been promoted as safer and more effective alternatives to more traditional hormone therapies, often by people outside of the medical community. In fact, little or no scientific and medical evidence exists to support such claims about ‘bioidentical hormones.’ Additionally, many ‘bioidentical hormone’ formulations are not subject to FDA oversight and can be inconsistent in dose and purity….”
Are compounded bioidenticals ever justified?
OBG MANAGEMENT: According to the FDA, compounding of drug products is justified only when a practitioner finds that an FDA-approved drug does not meet the patient’s needs. Do you think this is ever really the case, given the availability of FDA-approved bioidentical hormone preparations?
DR. PINKERTON: In rare cases, compounding of bioidentical hormones is justified, such as when a patient cannot tolerate an FDA-approved product. The problem is that women have been especially concerned about the safety of hormone therapy since the WHI, and bioidentical hormones have been promoted as being safer than FDA-regulated preparations, despite the lack of evidence of their safety or efficacy in peer-reviewed literature. So many women request them.
In a recent commentary, Boothby and Doering call bioidentical hormone therapy “a panacea that lacks supportive evidence.” They say, “It’s our belief that pharmacists are compounding these with the best intentions, but they are ill informed regarding the lack of scientific underpinning associated with efficacy and safety.”3
OBG MANAGEMENT: Do you ever prescribe bioidentical hormones?
DR. PINKERTON: Yes, but rarely, and primarily for women who can’t tolerate FDA-approved hormones or who, after adequate information and education, refuse FDA-approved hormone therapy.
Is salivary hormone testing informative?
OBG MANAGEMENT: Many clinicians who prescribe bioidentical hormones base the dosage on salivary hormone testing. They claim that this allows them to offer individualized formulations. Is this a reliable claim?