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.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 4
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.