FDA requires label changes for testosterone gel safety

July 16, 2009

The FDA is requiring manufacturers of 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 secondary exposure.

The FDA is requiring manufacturers of 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 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, of the FDA. "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 Dec. 1, 2008, the FDA has received reports of eight cases of secondary exposure to testosterone in children ranging from 9 months to 5 years of age. Since that time, additional reports of secondary exposure have been received by the agency and are currently 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 behavior.

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 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.