January 19, 2019
Compounded Hormones: Steer Clear

Compounded Hormones: Steer Clear

by Berkeley Wellness  

Women should not use com­pounded hormones (estrogen, progestin) to treat menopausal symptoms, such as hot flashes, or for sexual dysfunction or other conditions, according to a new Scientific Statement from the Endocrine Society, a leading professional organization in the field of endocrinology and metabolism. In recent years, other major medical groups have also cautioned or warned against the use of these products.

Compounded hormones, prepared by special pharmacies, are aggressively mar­keted as being “natural,” “bioidentical,” “customized,” and “safe.” They’ve been pro­moted by celebrities such as Suzanne Somers and Oprah Winfrey. The sales pitch clearly works, since about one-third of American women who use hormone therapy take these compounded products, according to a survey by the North American Menopause Society. That works out to about one in 10 women over age 40.

Conventional hormone therapy, using FDA-approved pharmaceutical-grade hormones, largely fell out of favor in 2002 when a major study from the Women’s Health Initiative linked it to increased risk of breast cancer, heart attacks, and strokes, at least in women mostly in their sixties. It is now rec­ommended primarily for short-term use to prevent severe menopausal symptoms.

But under the ever-seductive banner of “natural,” proponents of custom-compounded hor­mones continue to claim that supplemental hormones can not only treat menopausal symptoms (that’s true) but also help keep women healthy and youthful (that’s false). Moreover, compounded bioidentical hormones are safe, it’s claimed, largely because they are the same as the ones women have in their bod­ies. Such claims are unsubstantiated and misleading, for the following reasons:

  • There have been no large, long-term clinical trials on the effectiveness or safety of compounded hormones. The main con­cerns are overdosing, underdosing, and contamination, says the Endocrine Society.
  • Compounded hormones are far from “natural.” Their original sources may be plant compounds, but these have to undergo more than a dozen processing steps in a lab. There’s nothing wrong with that, except that there’s no FDA oversight of these pro­cesses, and errors can occur.
  • When it comes to compounded hor­mones, “bioidentical” is just a marketing term. Normally, it would simply mean that the hormones have the same molecular structure as those produced by the body. But in this context, it is meant to imply that the hormones are custom-compounded for the individual woman and are thus superior to standard FDA-approved formulations. Chemical analyses show, however, that com­pounded hormones usually are not exactly the same as those produced in the body and that they may vary in potency and purity.
  • The “customization” of this hormone therapy is questionable at best. To deter­mine women’s hormone needs, practitioners often use “alternative” monitoring regimens such as saliva testing, which are unreliable.

Bottom line: It’s hard to know how risky compounded hormones are, since they can vary from dispenser to dispenser and even from batch to batch. They are legal as long as they come from licensed pharmacists in response to valid prescriptions, but there’s little regulatory oversight and no formal sys­tem for reporting their adverse effects. If they work like conventional hormone therapy, they carry the same risks, but may have added hazards of their own. Women should stay with FDA-approved hormones and fol­low the guidance on the labels and inserts.

Also see Compounding Problems.