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Reporting a Medication Error

Danger of accidental testosterone exposure in children

211fb1d06f9479a7650fc3bb47b93c8b MYou may have seen some advertisements for testosterone gel products that men can apply to the skin when they have documented low testosterone (male hormone) levels. Restored testosterone may lead to increases in sexual desire, mood and energy.

Because the drug is applied to the skin by hand, handwashing is very important to avoid exposing other people, especially pregnant women and children, to the drug. This can occur when skin-to-skin contact is made. To minimize potential transfer of testosterone, patients should wash their hands immediately with soap and water after application of testosterone gel and they should cover the application site(s) with clothing after the gel has dried (e.g., a shirt). If unwashed or unclothed skin does come in direct contact with the skin of another person, the area of contact on the other person should be washed with soap and water as soon as possible. Not doing so risks harming a pregnant woman's fetus and also causing masculinizing effects in children and women.

Unfortunately, adverse effects have been seen in children who were accidentally exposed to testosterone through contact with another person. FDA has received reports of eight cases where children ranging in age from nine months to five years were exposed to the drug. Of the fully reviewed cases, adverse events reported in these children included enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased sexual feelings and aggressive behavior.

FDA notified healthcare professionals that it will require 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. FDA has provided recommendations and precautions to minimize the potential for secondary exposure. You can view the press release by clicking here.

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