Testosterone Gels Risky to Children - FDA Orders 'Black Box' Warning for AndroGel 1% and Testim 1% After Reports of Kids Affected by Adults' Use

May 7, 2009 -- The FDA today warned about the risks that testosterone gel products can pose to children inadvertently exposed to those products by adults.

The FDA is ordering a "black box" warning, the FDA's sternest warning, for two prescription topical testosterone gel products, AndroGel 1% and Testim 1%.

The FDA is requiring the boxed warning after getting reports of at least 20 children exposed to testosterone through contact with an adult using AndroGel 1% or Testim 1%.

Those children's adverse events 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 was no longer exposed to the product. But 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 because of a delay in recognizing the underlying cause of the signs and symptoms.

The FDA is also concerned about unapproved testosterone products, including those sold online. Those products carry the same risk to children. But because they're not supposed to be on the market in the first place, they can't get a black box warning.

About AndroGel 1% and Testim 1%

These prescription testosterone gels are approved by the FDA 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. Only AndroGel 1% is approved for application to the abdomen.

The FDA hasn't approved any testosterone gel products for use by women. But of the 1.4 million U.S. prescriptions filled in 2007 for AndroGel, about 25,000 were dispensed to women, the FDA notes.

AndroGel 1% and Testim 1% already have precautions on their labels about proper use of the products, such as where to apply it and covering the skin and washing hands afterward.

But in most of the cases in which children were affected, adults didn't use the gels correctly.

In some cases, adults forgot to wash their hands, or to cover the exposed area of their skin, or they applied the gel to their chest (which isn't an approved area for use), and then picked up or held infants or kids, FDA officials said in a news conference today.

The new boxed warning will provide additional information about the risk of secondary exposure (exposing someone other than the patient using the gel) and the steps that should be taken to reduce that risk.

AndroGel 1% is made by Solvay Pharmaceuticals, which pledges to work with the FDA regarding the black box warning, notes Neil Hirsch, a spokesman for Solvay Pharmaceuticals, in an email to WebMD.

A spokesperson for Auxilium Pharmaceuticals, which makes Testim 1%, was not immediately available for comment.

Safety Precautions

The FDA recommends taking the following precautions to minimize the potential for secondary exposure to AndroGel 1% or 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.
• Avoid any similar, but unapproved, products from the marketplace (including the Internet).

If a child develops inappropriate male sex characteristics or is exposed to testosterone gel, the FDA recommends contacting the child's doctor.