FDA: Testosterone Gel Products for Adults are Dangerous to Children

The Food and Drug Administration is requiring makers of two prescription testosterone gel products intended for adults to include more prominent “Black Box” warnings to warn users of the risk of injury to children who are exposed to the hormone products.

AndroGel 1% and Testim 1% have been linked to severe injuries to children who inadvertently came into contact with the gels used on adults. There have been at least eight reports of children ranging in age from nine months to five years being injured from secondary exposure to the testosterone gels, the FDA said.

Severe Injuries to Children Reported

Children exposed to the testosterone products have suffered from side effects including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior, according to the FDA.

Most of the children accidentally exposed to the testosterone gel products saw the symptoms disappear once they were no longer in contact with the products. However, some children have had to be hospitalized when their enlarged genitalia did not fully return to age-appropriate size or their bone age remained slightly above the child’s actual age, officials said.

One child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms.

Androgel is the most commonly dispensed testosterone gel product in the United States, with 1.4 million prescriptions handed out in 2007, the FDA said. Testim was prescribed about 370,000 times in 2007. Both products are approved for use in men who do not produce enough testosterone but also may be used for unapproved, “off-label” uses in women. The gels are applied once a day to the shoulders or upper arms. AndroGel also is approved for application to the abdomen.

FDA Orders Stronger Warning Labels

Citing the string of serious injuries to children, the FDA is cracking down on the makers of AndroGel and Testim. The current packaging of the products advises users to wash their hands after use and cover treated skin with clothing. However, many users have failed to follow those instructions and exposed young children to the gels, the FDA said.

Therefore, the FDA will now require “Black Box” warnings on the products’ labels to provide more information to users about the risk of secondary exposure in children and the steps that should be taken to reduce the risk. The makers of AndroGel and Testim must also develop a Medication Guide to ensure that the benefits of these products continue to outweigh their potential risks, the FDA said.

The FDA also issued recommendations for reducing the risks of secondary exposure of testosterone gels in children:

• Adults who use testosterone gels should wash their hands with soap and warm water after every application;

• Adults should cover the application site with clothing once the gel has dried;

• Adults should wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated;

• Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and

• Adults should note that use of any similar, but unapproved, products from the marketplace –including the Internet– that can result in the same serious adverse effects should be avoided.

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