(U.S. Food and Drug Administration) UPDATED 2009-05-07
The U.S. Food and Drug Administration (FDA) has announced that it is requiring manufacturers of two prescription topical testosterone gels, AndroGel and Testim, to include a boxed warning on the products’ labels. The FDA took this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with the products. Adverse events reported in these children included inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. The children's symptoms decreased when they were no longer exposed to the product, though some children's genitalia size and bone age remained greater than normal for their age. Both of these products are prescribed to men who either no longer produce testosterone or produce it in very low amounts.
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