We have sounded the alarm before about products touted as “bioidentical” or “natural” that sound like a safer alternative to conventional hormone therapy drugs but likely carry the same increased risks for heart attack, stroke, breast cancer, blood clots, and dementia. In fact, women who purchase compounded hormones to avoid “synthetic” or “pharmaceutical” hormones are often using exactly the same synthetic pharmaceutical hormones, purchased by special pharmacies (called compounding pharmacies) and remixed into pills or topical creams.
On Monday, we thanked the FDA for taking several steps we’d previously recommended to clarify FDA enforcement actions against individuals or firms that illegally make drugs under the banner of compounding. But we urged the FDA to do more. The FDA does not approve estriol, a hormone commonly used in “natural” hormone therapy products, for use in humans and its safety and effectiveness are unknown. We pushed for stricter labeling and marketing regulations to let consumers know that such products have not been approved by the FDA, may not meet FDA standards for good manufacturing practices, and have not been tested in clinical trials.
We will continue to fight for the rights of women everywhere to know the truth about the products they are prescribed.