Estriol—The FDA Got It Wrong

In January the FDA wrote a letter to 7 compounding pharmacies warning them about making false claims about estriol and other natural forms of bio-identical estrogen. Compounding pharmacies, which are not regulated by the FDA, have been advised to stop compounding estriol. My local paper, the Boston Globe published an article about this. I have submitted the following editorial in response to ensure that women will not be confused or misled by such unfounded accusations.

A recent story regarding “custom menopause drugs” prompted me to attempt to clear up the confusion surrounding the use of estrogen. In my medical practice, I have personally prescribed estriol and compounding hormones to hundreds of women for nearly ten years. Estriol, a form of estrogen that is naturally made by all women, is the predominant form of estrogen produced during pregnancy. There have been hundreds of studies citing the safety and effectiveness of estriol. It has been shown to reduce urinary infections, and other symptoms in menopausal women with fewer side effects than other forms of estrogen. Many believe it may also help prevent breast cancer, as studies have shown that women with breast cancer tend to have deficient levels of estriol, and pregnant women with high levels of estriol have added protection against the disease.

Steven Silverman is simply wrong in suggesting that “there is no scientific evidence that compounded hormones are biologically identical to the hormones produced by the body.” Estriol in compounding creams has the identical chemical structure found naturally in women. It has been a part of the U.S. Pharmacopeia for decades and has been coursing through the veins of all women since we were created. Furthermore, the FDA has no business attempting to regulate what licensed physicians and compounding pharmacists do. This exceeds the bounds of their authority. Perhaps its not surprising that this latest FDA “concern” was prompted by Wyeth Labs, makers of the now largely discredited synthetic hormone, Prempro.

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