Bisher AKIL, MD

Testim & Androgel have new FDA warning

In General Health on May 14, 2009 at 7:03 pm

The FDA is requiring that two prescription testosterone gels — AndroGel 1% and Testim 1% — carry boxed warnings after reports of adverse events in children who had secondary exposure to the gels.

 

Eight children (aged 9 months to 5 years) were inadvertently exposed to the gels through skin-to-skin contact with people using the products, which are approved for men who produce low levels of testosterone. The adverse events in children included inappropriate genital enlargement, early pubic hair growth, advanced bone age, increased libido, and aggressive behavior. Usually, these symptoms regressed when the children were no longer exposed.

To minimize the risk for secondary exposure, the FDA recommends that adults using the gels:

  • wash their hands after every use;
  • cover the application area with clothing after the gel has dried;
  • wash the area when skin-to-skin contact with another person is expected.

In addition, other people should not touch the application area. 

FDA release could be viewed at

http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html

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