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U.S. Department of Health and Human Services

Drugs

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Testosterone Gel Safety Information

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).