The U.S.Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels. The agency is requiring this action after receiving reports of adverse effects in CHILDREN who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).
The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved for application to the abdomen. Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing.
Adverse events reported in many cases with secondary exposure of children ranging in age from nine months to five years, included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.
The FDA recommends the following precautions be taken to minimize the potential for secondary exposure of children:
1. Adults who use testosterone gels should wash their hands with soap and warm water after every application;
2. Adults should cover the application site with clothing once the gel has dried;
3. Adults should wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated;
4. Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
5. Adults should note that use of any similar, but unapproved, products from the marketplace –including the Internet– that can result in the same serious adverse effects should be avoided.
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