Posts Tagged ‘testosterone’

In 2007, 1.4 million prescriptions for AndroGel—the most commonly dispensed gel form of testosterone—were dispensed by U.S. retail pharmacies. Testim is the other prescription topical testosterone gel, both of which are used in men who either produce low levels of testosterone or no longer produce testosterone. They are also prescribed for some off-label uses in women. Safety concerns have arisen over adverse affects from children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Currently, the FDA has received eight reports of secondary exposure in children with more reports being reviewed. 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. Labels on current testosterone gel products caution the user to thoroughly wash their hands after applying the product and to cover the treated skin area with clothing. Failure to do so could result in exposure of the testosterone to others with whom they physically contact. The FDA is responding to the situation by requiring manufacturers to include these new warnings on their product labels.

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