The FDA recently announced that it is going to start â€œcracking downâ€ on Internet sales of bioidentical hormones. They began by ordering seven specific pharmacies to stop making â€œfalse and misleadingâ€ statements about the bioidentical hormones they compound for individual patients.
I am very happy to see the FDA take this action. The companies that make bioidentical hormones typically claim that these drugs are better and safer than the hormone therapies pharmaceutical companies produce to treat menopausal symptoms.
But not only is there no data to suggest that bioidentical hormones are safe, there is reason to believe that they are dangerous. Estriol, which is the type of estrogen typically used in these products, is the form of estrogen that increases greatly during pregnancy, and we know that breast cancer risk increases when a woman is pregnant and for the three years after she gives birth.
In addition, we know that postmenopausal women who have high levels of their own estrogen or testosterone have been found to have higher risks of breast cancer. You cannot get more bioidentical than your own hormones, and, as these studies make clear, even our own hormone levels are not always safe.
Bottom-line: Women need high levels of hormones to reproduce. These levels then scale down to a safer level with menopause. Artificially maintaining these levels at premenopausal levels is not safe.
The second issue is compounding. While there is certainly some benefit to tailoring a dose to an individual patient, we do not know what the right levels are for postmenopausal women, which means it is virtually impossible to do this. Moreover, there is no FDA scrutiny of these labs or drugs.
You can read more about bioidentical hormones on our site here.
This piece by the National Women’s Health Resource Center also provides a good overview of options for treating menopausal symptoms and explains what we know–and don’t know–about bioidentical hormones.