Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
Thu, 07 May 2009 11:03:00 -0500

The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1 percent and Testim 1 percent, 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).

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