Label Changes for:
AndroGel (testosterone gel)
November 2011
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
March 2011
PATIENT COUNSELING INFORMATION
- To wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into their system.
MEDICATION GUIDE
How should I use AndroGel?
- To wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into their system.
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 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
(new text added)
- 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.
November 2011
