AndroGel 1% and AndroGel 1.62%

AndroGel 1% and AndroGel 1.62% are both prescription products used for daily testosterone replacement therapy (TRT). They are manufactured by Abbott Laboratories. The gel is applied to the skin of the shoulders and upper arms. AndroGel 1% may also be applied to the abdomen.

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.

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.

AndroGel 1% was approved by the FDA in Feburary 2000. In 2007, 1.4 million prescriptions for AndroGel 1% – the most commonly dispensed gel form of testosterone – were dispensed by U.S. retail pharmacies. Approximately 25,000 of those were dispensed for off-label use in women.

In May 2009, the FDA announced it would required AndroGel 1% to carry a boxed warning of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products.

The FDA placed a Black Box warning about the risks of AndroGel 1% to children and women in September 2009.

Androgel 1.62% was approved by the FDA in April 2011, and included the black box warning about secondary testosterone exposure for children and women.

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.  The area where the gel was applied should be covered, and patients are warned that others should not come into contact with the skin where the gel was applied.

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.

The possibility of secondary exposure to testosterone gel should be brought to the attention of a health care provider.

Sources:

http://www.rxabbott.com/pdf/androgel_PI.pdf

http://www.rxabbott.com/pdf/androgel1_62_PI.pdf


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