FDA Actions

Two topical testosterone gel products must carry boxed warnings on their labeling after an FDA ruling that the gels may cause adverse effects in children who are inadvertently exposed by contact with adults who are using the products. Testosterone gel is approved for use in men with low testosterone levels and is applied to the shoulders and abdomen. The gels are also occasionally used for off-label indications in women. The FDA has received reports of several cases of secondary exposure in children, and more cases are under review. Exposed children showed signs of enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. The FDA recommends that adults wash their hands after application of the gel, cover the application site with clothing, and wash thoroughly where any skin to skin contact may occur. The products affected by the boxed warning include AndroGel^® 1% and Testim^® 1%.

The FDA has approved a new atypical antipsychotic drug for treatment of schizophrenia. Iloperidone (Pantheon, Inc.) will carry the same boxed warning as other atypical antipsychotics regarding the increased risk of death associated with dementia-related psychosis. Iloperidone will be marketed as Fanapt™.

The FDA is warning consumers to immediately stop using Hydroxycut dietary supplements marketed for weight loss, as fat burners, as energy enhancers, as low-carb diet aids, and diuretics. Hydroxycut products have been associated with a number of serious liver injuries including jaundice and elevated liver enzymes, liver damage requiring liver transplant, and liver failure. Other health problems include seizures, cardiovascular disorders, and rhabdomyolysis. One death has been reported. Iovate Health Sciences is recalling 14 products under the Hydroxycut brand.