This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Men's Health  • Men's Health, Other  • Neurology  • Neuroendocrinology  • Pediatrics  • Pediatrics, Other  • Drug Therapy  • Adverse Effects  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

Rebecca Voelker

JAMA. 2009;301(23):2428.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Despite label precautions, . . . [Full Text of this Article]

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?