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
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
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.
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