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).
Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
FDA News Release (5/7/2009)
AndroGel Letter: Safety Labeling Changes and Risk Evaluation and Mitigation Strategies (REMS)(PDF - 183KB)
Testim Letter: Safety Labeling Changes and Risk Evaluation and Mitigation Strategies (REMS)(PDF - 110KB)