The prescription testosterone creams AndroGel 1% and Testim 1% have caused serious adverse reactions in children who have been inadvertently exposed to the products, federal regulators warned today. The severity of such side effects has prompted the Food & Drug Administration (FDA) to order a new black box warning for the testosterone creams.
AndroGel 1% and Testim 1% are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. AndroGel 1% is also approved for application to the abdomen.
Adverse events have occurred when children have come into physical contact with a person treated with either AndroGel 1% or Testim 1%. These side effects may include inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.
As of December 2008, the FDA has received reports of eight cases of such side effects in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review.
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 one case, a child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms.
Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing. In most of the cases reported to the FDA, users of AndroGel 1% and Testim 1% failed to follow those instructions, resulting in direct contact between treated skin and a child. According to the agency, the new labeling on the testosterone creams will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk.
The FDA recommends the following precautions be taken to minimize the potential for secondary exposure to AndroGel 1% and Testim 1%:
* 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.
In addition to the new black box warning, the FDA is also requiring the makers of AndroGel 1% and Testim 1% to develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks.
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