Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has placed a black box warning on two separate topical testosterone gels following reports of secondary exposure to children, which can cause serious symptoms in children such as enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior. The two drugs listed by the FDA include AndroGel 1 % for topical use and Testim 1 % topical gel.

The FDA warnings advise users of the product keep children away from unwashed or unclothed application sites in men using the gel. Women should also heed the warnings as they, too, can be exposed secondarily to the drug if proper precautions are not taken by the user.

Testim recommends that the drug be only applied to the shoulders or upper arms, or areas of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt.

The boxed warnings were included in the FDA’s September 2009 summary of drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Both AndroGel and Testim will have updates to their drugs’ packaging to include the boxed warning as well as other warnings, precautions and adverse reactions.

Consumers with questions about the use and possible secondary exposure to AndroGel or Testim should contact their healthcare provider. Individuals who have experienced any adverse events associated with these or any medications should contact the Food and Drug Administration Medwatch Reporting program.

This entry was posted on Thursday, October 22nd, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.