Testim (testosterone gel) 1% topical gel

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 

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.