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Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes ROCKVILLE, Md -- May 7, 2009 -- The US Food and Drug Administration (FDA) today announced that it is requiring manufacturers of 2 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). "These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly," said Janet Woodcock, MD, FDA's Center for Drug Evaluation and Research. "We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure." Despite the currently labeled precautions, as of December 1, 2008, the FDA has received reports of 8 cases of secondary exposure to testosterone in children aged 9 months to 5 years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behaviour. In most cases, the signs and symptoms regressed when the child no longer was exposed to the product. However, in a few cases, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age. In some cases, children had to undergo invasive diagnostic procedures and, in at least 1 case, a child was hospitalised and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms. In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child. The required label changes will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk. The FDA also is requiring that the manufacturers of these products develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these gels to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone. -- Online: www.fda.gov/MedWatch/report.htm -- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: (800) FDA-0178 --Phone: (800) FDA-1088 SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version