Testosterone Gel Prompts Safety Concerns

Testosterone gel is meant for men who no longer produce enough testosterone, but children are suffering ill effects from unintentional exposure.

That is spurring the FDA to require two manufacturers to include boxed warnings on the products' labels.

The gels, AndroGel 1% and Testim 1% are supposed to be applied by men once daily to the shoulders or upper arms. The current labels tell users to wash their hands after applying the gel and to cover the treated skin with clothing.

However, the FDA has received eight reports of children who had been exposed to the gel. These children, ranging in age from nine months to five years, suffered negative effects such as inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.

In most of these cases, the child's testosterone exposure was caused by the user of the gel failing to follow the instructions, resulting in direct contact between the child and treated skin.

The symptoms went away in most of the cases after exposure of the child to the product was halted. However, in a few cases, some negative effects remained.

"These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in a written statement. "We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure."

AndroGel is the most frequently used testosterone gel, with 1.4 million prescriptions dispensed in 2007.

The FDA is warning that if a child may have been exposed to testosterone and is showing inappropriate development of male secondary sexual characteristics, a health care provider should be informed.

Adult users of testosterone gel should take these measures to minimize secondary exposure to others:

Testosterone gel users should wash their hands with soap and warm water after every application;

They should cover the skin with clothing once the gel is dry;

They should wash the skin with soap and warm water thoroughly if there may be direct skin-to-skin contact with another;

Children and women should avoid contact with the application site on men who are using the product;

Use of any similar, but unapproved, products that are advertised on the Internet or elsewhere should be avoided.

For more information, you can read the full announcement from the FDA here.