FDA recalls dietary supplements containing aromatase inhibitors

The FDA has notified consumers of a recall of products marketed as dietary supplements containing aromatase inhibitors. These products are sold under the names Arom-X, Arom-X UTT, Arom-XL, 4-AD, Decavol, ArimaDex, Clomed, Off Cycle II Hardcore, Reversitol. The FDA has notified the manufacturers that these products do not meet the definition of a dietary ingredient and therefore the products are in violation of provisions of the Food, Drug and Cosmetic Act.

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. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. 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 who have these products in their possession should stop taking them immediately and contact their healthcare provider if they experience any adverse effects related to the use of the products.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226343.htm.