Are Bioidentical Hormones Safe?

Susan J. Wysocki, RN-C, NP, FAANP


November 02, 2009


Many patients ask me to prescribe compounded hormones, which they believe are safer. Some bring in saliva test results, and complicated charts and graphs with a suggested prescription attached. How should I respond?

Response from Susan J. Wysocki, RNC, NP, FAANP
President and CEO, National Association of Nurse Practitioners in Women's Health, Washington, DC

There is no evidence that so-called bioidentical hormones compounded in a pharmacy are safer than other hormone products. Furthermore, unlike insulin or thyroid hormone, female hormones cannot be titrated to customize a formula for an individual woman.[1] Female hormone levels are very dynamic and no single measurement can capture what the hormone levels might be the next day or even later on the same day. In some circumstances, blood levels may help a clinician understand why a woman might not be responding to therapy.[1] Overall, however, the woman herself is her own best "bioassay" for determining whether she needs hormonal therapy or when the dosage should be adjusted. Listening to her describe her menopausal symptoms and how well she has responded to therapy gives the clinician the best idea of what is going on in the target tissues.

In January of 2008 the FDA sent warnings to a number of large compounders of bioidentical hormone replacement therapy (BHRT) products, expressing concern about these manufacturers' claims about the safety, effectiveness, and superiority of their products. In that same memo, the US Food and Drug Administration (FDA) warned about the use of estriol, a weak estrogen that has not been approved by the FDA for use in any product.[2] Nevertheless, countless Websites, celebrities, other individuals, and pharmacies continue to make claims about BHRT. The FDA considers the term BHRT a marketing term.

Saliva tests are not a valid measure of female hormone levels. Female hormones that are found in saliva do not reflect what might be going on in the target tissues -- including the brain, the bones, etc.[2] It is in my opinion that these tests and products are a waste of money that would be better spent on something like a massage. Again, listening to a woman and what she says about her symptoms is the best way to "titrate" female hormones.

There are several issues about which clinicians should be aware. First of all, compounded products do not come with the class labeling that is mandated for any other menopausal hormone product, including warnings, black box, and other information. The absence of this label places on clinicians the burden of describing to the patient and documenting all these warnings. Second, there is no guarantee of the contents or purity of the compounded products. There is not enough oversight by the FDA to inspect all compounding pharmacies to determine if their products contain what they claim to contain.

Overall, there are no studies that demonstrate the superiority of any hormone product over another -- compounded or not. The labels for all FDA- approved menopausal hormones are the same. There are some intriguing data from a case-controlled study of transdermal estrogens (not a compounded product) that suggest that there are fewer associated risks for blood clots even among women who are at higher risk for blood clots.[3] The results are biologically plausible because of the lack of first-pass liver effect. However, as intriguing as these data are, I caution clinicians about making any absolute statements about the safety of transdermals. We need more data.

A wide variety of FDA-approved products is available to American women. These include oral forms, various transdermal forms, and a systemic vaginal ring. A wide range of doses is available. Many products fit the definition of bioidentical as used by the compounding pharmacies. Most of these products are covered by insurance. Compounding is very legitimate when a patient cannot take or tolerate FDA-approved medicines.

Ultimately, the clinician's job is to help the menopausal woman ameliorate her symptoms, feel well, and have a good quality of life. The current range of FDA- approved options meets the needs of most women. Compounding claims have been a marketing ploy to seduce women and clinicians into taking or prescribing something for which the evidence of benefit is lacking.


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