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Medical News & Perspectives
June 17, 2009

Children’s Exposure to Testosterone Gel Spurs FDA to Order Boxed Label Warning

JAMA. 2009;301(23):2428. doi:10.1001/jama.2009.810

The US Food and Drug Administration (FDA) announced in early May that it will require the manufacturers of 2 topical testosterone gel products (AndroGel 1% and Testim 1%) to include a boxed warning on the product label. The FDA's announcement followed reports to the agency of adverse effects in children who inadvertently were exposed to testosterone through contact with individuals who had used the products.

The gels are approved for use in men who produce little or no testosterone. They are applied topically to the shoulders or upper arms; AndroGel 1% is approved for application to the abdomen. Current label instructions advise patients to wash their hands and cover the treated area with clothing after using the product. The FDA noted that most cases of adverse events in children occurred because patients failed to follow the label instructions, resulting in skin-to-skin contact with a child.