Safety concerns prompt labeling change on testosterone gels

After receiving reports of adverse effects in children who were inadvertently exposed to two testosterone gels, the FDA announced in May 2009 that manufacturers need to add a boxed warning on the products’ labels. AndroGel and Testim are prescribed for men who produce little or no testosterone. Users rub the gels into the shoulders or upper arms.

Unfortunately, eight children developed side effects including enlarged genitalia, premature development of pubic hair, increased libido, and aggressive behavior after exposure to the gels. The children ranged in age from 9 months to 5 years old. In most cases, the signs and symptoms went away after their exposure to the gels ended.

After a man applies the gel, he should wash his hands with soap and warm water and cover the treated skin with clothing. He should also wash the treated skin if he anticipates skin-to-skin contact with another person.

Consumers should report any problems with these products to the FDA online at www.fda.gov/medwatch/report.htm, or by phone at 800-FDA-1088 (toll-free).

Originally published July 1, 2009; Last reviewed April 12, 2011