TESTIM is a prescription medicine used to treat adult males who have low or no testosterone. It is a testosterone-containing gel that is applied to the skin of the shoulders and upper arms. Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Reported cases involved children ranging in age from 9 months to 7 years old.
Physicians should advise patients of the reported signs and symptoms of secondary exposure, which may include the following:
- In children: unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, aggressive behavior and advanced bone age.
- In women: changes in hair distribution, increase in acne, or other signs of testosterone effects.
TESTIM is manufactured for Auxilium Pharmaceuticals, Inc., by DPT Laboratories, Ltd. It was approved by the FDA in October 2002. There were approximately 400,000 prescriptions dispensed for Testim 1% in 2008.
Since the initial marketing approval of testosterone gel in 2000 to May 2009, FDA's Adverse Event Reporting System (AERS) has received 20 pediatric postmarket reports of secondary exposure to topical testosterone gel.
The FDA placed a boxed warning about the risks of TESTIM 1% to children and women in September 2009, as well as updated safety labeling changes to the Warnings, Precautions and Adverse Reactions sections of the label.
The area where the gel is applied should be covered, and patients are warned that others should not come into contact with the skin where the gel was applied.
The possibility of secondary exposure to testosterone gel should be brought to the attention of a health care provider.
In at least one reported case of secondary exposure to testosterone in children, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirt and other fabrics such as towels and sheets.
In most cases, signs and symptoms of testosterone exposure regressed with the removal of the testosterone gel exposure. However, there were cases where enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age.