Testosterone gel products gain boxed warning

The FDA has announced that it will require a boxed warning to be included on the product labeling for two prescription topical testosterone gel products, AndroGel (testosterone 1%, from Solvay Pharmaceuticals) and Testim (testosterone 1%, from Auxilium Pharmaceuticals). These products are use for testosterone replacement therapy in men who no longer produce testosterone or produce it in very low amounts. The FDA is also requiring that the manufacturers of these products develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy (REMS). The FDA is requiring this action after receiving reports of adverse effects in children inadvertently exposed to testosterone through contact with patients treated with these products (secondary exposure).

Despite currently labeled precautions, as of December 1, 2008, the FDA has received reports of eight cases of secondary exposure to testosterone in children 9 months to 5 years of age. Adverse events reported in these children include inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. Additional reports have been received and are presently under review. The FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

Signs of inappropriate development of male secondary sexual characteristics in children and the possibility of secondary testosterone exposure should be brought to a healthcare provider’s attention.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm149346.htm.