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Reports of Adverse Effects in Children Prompt FDA Action on Testosterone Gel

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The U.S. Food and Drug Administration (FDA), has announced that it is requiring manufacturers of 2 prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels.

The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).

Despite the currently labeled precautions, as of Dec. 1, 2008, the FDA has received reports of 8 cases of secondary exposure to testosterone in children ranging in age from 9 months to 5 years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review.

Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), 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 some cases, children had to undergo invasive diagnostic procedures and, in at least 1 case, a child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms.

Signs of inappropriate virilization (development of male secondary sexual characteristics) in children and the possibility of secondary testosterone exposure should be brought to a health care provider's attention.

The FDA recommends the following precautions be taken to minimize the potential for secondary exposure:

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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Last updated on May-7-09

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