AndroGel (testosterone gel) 1% for topical use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

 

Summary View

 

BOXED WARNING

WARNING: Secondary Exposure to Testosterone

• Virilization has been reported in children who were secondarily exposed to testosterone gel.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

WARNINGS AND PRECAUTIONS

Potential for Secondary Exposure to Testosterone

• Secondary exposure to testosterone in children and women can occur with testosterone gel use in men...
• Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution...

ADVERSE REACTIONS

Postmarketing Experience

• Secondary Exposure to Testosterone in Children
  Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. Signs and symptoms of these reported cases have included enlargement of the clitoris...

PATIENT COUNSELING INFORMATION

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• Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children with signs and symptoms including enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.