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U.S. Department of Health and Human Services

Safety

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Testim (testosterone gel) 1% topical gel

 

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

 

November 2011

Summary View

Medication Guide

What is the most important information I should know about testosterone gel?
  • Signs and symptoms of early puberty in a child may include:
    • enlarged penis or clitoris
    • early development of pubic hair
    • increased erections or sex drive
    • aggressive behavior

 

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 

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...

PRECAUTIONS

  • Children and women should avoid contact with Testim application sites on the skin of men using Testim.
  • Testim should only be applied to the shoulders or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt).
Information for Patients
  • Secondary exposure to testosterone in children and women can occur with the use of testosterone gel products in men. Cases of secondary exposure to testosterone have been reported...
  • Unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections...

ADVERSE REACTIONS

Secondary Exposure to Testosterone in Children
  • Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products.