FDA Orders Label Warning for Testosterone Gels
Mar-05-2015

Children can experience troubling health effects if they come into contact with topical testosterone gels used by some American men, and the United States Food and Drug Administration announced Thursday that two of these preparations would now carry boxed warnings to highlight the risk.

Accidental pediatric exposures to the gels can occur when the "consumer forgets to wash their hands or forgets to cover a treated area, and then has close contact with the child, or may have not waited for their skin to dry and then picks up a child," Dr. Dianne Murphy, the FDA's director of the Office of Pediatric Therapeutics within the Office of the Commissioner, said during a Thursday afternoon press conference.

Over time, these exposures can lead to premature and/or abnormal development of male characteristics in both boys and girls, the FDA said.

The two affected prescription medications are AndroGel 1%, made by Solvay Pharmaceuticals, and Testim 1%, made by Auxilium Pharmaceuticals. These are currently the only topical gel drugs approved by the FDA to address an insufficient or total lack of testosterone production among men.

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