Adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events.
The FDA concludes that products containing aromatase inhibitors have a reasonable probability of resulting in permanent impairment of a body structure or function in at-risk consumers. FDA has notified manufacturers that these products do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.
Many of these products are or had been sold nationwide, both in retail stores and via the internet directly to consumers. Some have been discontinued but some online retailers may still have remaining inventory that they are offering for sale.