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The Food and Drug Administration (FDA) announced on May 7, 2009, 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 bad side effects in children who were exposed to testosterone by accident through contact with another person being treated with these products (secondary exposure).
FDA approved the gels for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved to apply to the abdomen.
Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing. Despite these labeled precautions, as of Dec. 1, 2008, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from 9 months to 5 years. FDA continues to receive and review additional reports of secondary exposure.
In most of the cases, users of these products failed to follow the instructions for appropriate use, resulting in direct contact between the treated skin and the child.
Side effects reported in children include
In most cases, the signs and symptoms lessened when the child was no longer exposed to the product. However, in a few cases, enlarged sexual organs did not fully return to the child's age-appropriate size and bone age remained greater than the child's chronological age.
FDA is requiring the manufacturers of these products to
AndroGel 1% is manufactured by Solvay Pharmaceuticals in Marietta, Ga. Testim 1% is made by Auxilium Pharmaceuticals in Malvern, Pa.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html
FDA Drug Safety Initiative Fact Sheet
www.fda.gov/oc/factsheets/initiative.html
Drugs@FDA: Information on FDA-Approved Drugs
www.accessdata.fda.gov/scripts/cder/drugsatfda/
Date Posted: May 8, 2009