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