The FDA respects a healthcare provider’s decision that his or her patient should receive a pharmacy-compounded hormone replacement drug, but the FDA also wants to assure that women and their healthcare providers understand the risks and benefits of those drugs. The FDA has seen claims that compounded bioidentical hormone drugs avoid the risks of FDA-approved treatments for the symptoms of menopause, and that these drugs can prevent or reduce the risk of serious illnesses such as heart disease, stroke and breast cancer. The FDA knows of no credible scientific evidence supporting these claims.
Some bioidentical hormone replacement drugs contain an ingredient called estriol. The safety and effectiveness of estriol has not been credibly proven and the FDA does not condone estriol use for compounding without an FDA-sanctioned investigational drug application.
Many medical and patient-protection groups—including the American College of Obstetricians and Gynecologists, the American Medical Women's Association, the American Society for Reproductive Medicine, the Association of Reproductive Health Professionals, and the Black Women's Health Imperative—have publicly supported the FDA’s management of compounded bioidentical hormone drugs.
Some bioidentical hormone replacement drugs contain an ingredient called estriol. The safety and effectiveness of estriol has not been credibly proven and the FDA does not condone estriol use for compounding without an FDA-sanctioned investigational drug application.
Many medical and patient-protection groups—including the American College of Obstetricians and Gynecologists, the American Medical Women's Association, the American Society for Reproductive Medicine, the Association of Reproductive Health Professionals, and the Black Women's Health Imperative—have publicly supported the FDA’s management of compounded bioidentical hormone drugs.
Published 01/12/2009
