The two products in question are AndroGel 1 percent and Testim 1 percent and are used by men who no longer produce testosterone naturally, or produce it in very low quantities. The medication, which comes in gel form is applied once daily to the shoulders or upper arms. AndroGel 1 percent can also be applied safely to the abdomen and is the only of the two approved by the FDA for use on the abdomen.The manufacturers warn patients to thoroughly wash their hands afterwards and to ensure that the area applied is well covered with clothing. AndroGel 1 percent is manufactured by Marietta, Ga.-based Solvay Pharmaceuticals. Testim 1 percent is made by Auxilium Pharmaceuticals of Malvern, Pa.
The concern is secondary exposure and especially to children. Here's why: testosterone is a powerful influence on young children, to the point of fostering physical changes to immature genitalia and even the early growth of pubic hair. Prior to December 1st of last year the FDA received 8 reports of secondary exposure to testosterone in children ranging in age from 9 months to 5 years.
Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior.
Thankfully in most of the cases the symptoms identified above regressed when the child was no longer exposed.
But not always. A few of the children (and their parents) were made to face the unhappy circumstance of genitalia that did not return to normal dimensions after secondary exposure to testosterone stopped and bone age did not improve to represent the child's true chronological age.
In some cases, invasive diagnostic procedures were required. In one, a child was hospitalized and was faced with surgery as a result of failure to diagnose the condition in a timely manner.
Since last December, there have been further reports of adverse reactions to secondary exposure to testosterone gel. In most of the cases identified, users of the topical testosterone gel failed to follow specific instruction for washing hands and for covering the affected skin. The result fostered direct contact between treated skin and the child.
"These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure."
The FDA reports that in 2007 1.4 million prescriptions for AndroGel 1 percent were dispensed by US retail pharmacies. Approximately 25,000 of those were dispensed for off-label use in women. Some 370,000 prescriptions were dispensed for Testim, according to data from SDI: Vector One National.
The FDA lists a number of precautionary tasks necessary for the safe use of topical testosterone gels, not the least of which includes the correct and thorough washing of hands, the covering of treated skin and to ensure that treated skin is only covered after the treated area has properly dried.
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However, the FDA is also quick to point out that similar products other than those which have been identified in this public communiqué would also have similar risks. The FDA expressly pointed to the Internet as one possible source for such unapproved medications that would have the same horrific adverse affects on children, as AndroGel 1 percent and Testim 1 percent.
If you suspect your child has been in close contact with someone who regularly uses topical testosterone gels—or worse, if you have noticed unnatural changes to genitalia in your child, consult the services of a qualified medical professional immediately.
You may wish to seek legal counsel as well.