On May 7, 2009, the Food and Drug Administration ("FDA") issued an advisory notifying healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. The FDA has received numerous reports of secondary exposure to testosterone in children ranging in age from nine months to five years. Adverse events reported in children inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms.
If you or your child has been harmed by a topical testosterone gel product, please contact us to discuss your legal options.