Latebreakers: FDA warns compounding pharmacies about bio-identical hormones

January 28, 2008

FDA warns compounding pharmacies to stop using estriol

The FDA has issued an enforcement action against seven pharmacy operations that compound so-called bio-identical hormone drugs used to treat the symptoms of menopause. According to the agency, the prepared products may contain estriol, a drug that has not been approved by the FDA, and the pharmacies have made false and misleading claims about the products, calling them a treatment for Alzheimer's disease, cancer, stroke, and other diseases for which there is no scientific proof of their safety or efficacy. The FDA said it expects a response from the cited pharmacies within 15 days. Any company wishing to use estriol in its preparations must first seek approval through submission of an NDA, agency officials said. In addition, the FDA has posted an article on its consumer health Web site, Bio-identicals: Sorting Myths from Facts, to help educate the public on the issue. The FDA said its actions are a response to a citizen's petition it received from Wyeth Pharmaceuticals concerning the compounded drugs.