FDA Orders Label Warning for Testosterone Gels

May 8 -- THURSDAY, May 7 (HealthDay News) -- Children can experience troubling health effects if they come into contact with topical testosterone gels used by some American men, and the U.S. Food and Drug Administration on Thursday announced 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.

Men typically rub the gels onto their upper arms or shoulders, according to the FDA.

According to the FDA, in 2007, pharmacies dispensed about 1.4 million prescriptions for the most popular medication, AndroGel, and about 370,000 prescriptions for Testim.

In addition to the new warning box, manufacturers will also have to develop a medication guide "to ensure that consumers who use these products are aware about the risk to children of secondary exposure," Murphy said.

The new requirements arose after a thorough review of eight cases, reported since December 2008, in which children -- ranging from as young as nine months to as old as five years -- experienced a range of adverse side effects as a result of coming into direct and repeated contact with the treated skin of an adult user of either gel.

This type of exposure triggered "inappropriate virilization" among the young patients, Murphy said, including the onset of premature male characteristics in boys and inappropriate male characteristics among girls. The effects included "inappropriate enlargement of the penis or clitoris, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior" among the eight cases analyzed, Murphy said.