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Posted September 20, 2010

Many Supplements Recalled for Hormone-Affecting Compounds

On September 20, 2010, the U.S. FDA posted a Safety Notice regarding the recalls of several products marketed as dietary supplements that contain aromatase inhibitors, commonly known as "ATD." 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 Safety Notice covers a series of recalls reported by the FDA over the past several days of products including Advanced Muscle Science (Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol), ArimaDex, Clomed (see separate posting by on 9/15/10), Off Cycle II Hardcore, iForce - Reversitol.

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.

Consumers who have any of these products in their possession should stop using it immediately. If consumers experience any adverse side effects due to its consumption they should contact a physician.

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