Warnings Slapped On Testosterone Gels: Danger To Kids

The Food and Drug Administration has announced a "black box" warning label for testosterone gels following reports of children being harmed by inadvertent exposure to the hormone.

FDA officials say they've received multiple reports of young children — under the age of 6 —showing signs of puberty after coming in close contact with adults using testosterone gels.

As a result, the FDA is requiring the manufacturers of the drugs AndroGel and Testim to add the black box warning, the toughest type available. The drugs already carried precautions about the problem.

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

The reported side effects in kids include premature sexual development and aggressive behavior.

The gels are approved for use in men whose bodies either don't produce testosterone or produce it in minimal amounts.