Testosterone Gels Get New Black Box Warning

Recently, the FDA announced that two testosterone gel products must have a new black box warning. The products are AndroGel 1% from Solvay Pharmaceuticals and Testim 1% from Auxilium Pharmaceuticals. The new boxed warning must alert users to the dangers of secondary exposure to children. As of December 1, 2008, there had been adverse event reports of 8 children who had secondary exposure to the testosterone gel products. The children, ages 9 months to 5 years old, who were the subject of the adverse event reports had been in close contact with users of the testosterone gel products. According to the FDA, those children had developed "inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior." Though most symptoms regressed when the child’s exposure to the product stopped, some symptoms did not fully disappear. According to FDA medical experts, the adverse events likely resulted from the children having skin-to-skin contact with areas where the gel had been applied. The new labels must highlight the following warnings for testosterone gel users: they should thoroughly wash their hands after applying the product, they should cover the area where the gel has been applied, they should thoroughly wash the application site before skin-to-skin contact with another person, and women and children should avoid contact with application sites. Also, people should avoid similar, unapproved products on the market.