AndroGel, a prescription topical testosterone gel manufactured by Abbott Laboratories, is used to treat adult males who have low testosterone and other conditions associated with testosterone deficiency. AndroGel is intended to be used by adult males only. AndroGel comes in a pump bottle and is to be applied on the shoulders, upper arms and depending on the dosage, the stomach area. AndroGel’s label indicates that it is to be applied once daily after showering or bathing. Due to AndroGel’s topical application method, there is an extremely high risk of transfer to others. Transfer of AndroGel to women and children may occur through skin-to-skin contact with an adult using AndroGel as well as exposure through clothing, bed linens, and other shared exposures.

An FDA report regarding risks of children exposed to AndroGel through indirect transfer from their fathers outlines the horrific results. Male children who have come in contact with AndroGel have experienced: pubic hair development, enlarged penis, advanced bone age and/or growth velocity, increased testosterone levels, and hypersexualized behavior. Female children have experienced clitoromegaly (an abnormal enlargement of the clitoris), development of pubic hair, hypersexualized behavior, and elevated testosterone levels.

The 2009 FDA report looked at nine cases of indirect exposure to children. One case involved a 16-month-old boy, who had an enlarged penis with erections, pubic hair, increased testicular volume, and advanced bone age. In that case, the father was using testosterone gel twice daily for about a year, and the child slept in the same bed as the parents and the father would hug the baby boy on his chest with skin-to-skin contact. In another male case, an infant had a testosterone level of eight times that normal for an infant. A five-year old boy experienced elevated testosterone levels, advanced bone age, preoccupation with masturbation, and was “thrust into puberty.” In that case, the father would put on a shirt immediately after applying the gel, but the child slept with his parents.

The results seen in female children are equally disturbing. A nine-month-old girl experienced clitoromegaly and elevated testosterone levels, which required the girl to undergo a clitoral reduction surgery. In that case, the father applied AndroGel in the morning, went to work, and showered upon his return home; no skin-to-skin contact was reported. Two sisters, two and four years old, were exposed to AndroGel through clothing and sheets on the bed. The girls experienced pubic hair growth, clitoromegaly, advanced bone age, and a preoccupation with masturbation. In each case, when use of AndroGel was discontinued or the children were removed from exposure, the symptoms improved. Unfortunately, however, long-term effects such as sterility have been seen in both male and female children.

Using AndroGel around children is extremely dangerous. In light of the extraordinary consequences to young children if they are exposed to AndroGel, it is unclear why physicians would not prescribe and patients would not insist on testosterone shots as a safer alternative. Monthly testosterone shots are just as effective, result in no risk of harm to women or children, and cost approximately $30 per month (as compared to the $400+ per month cost of AndroGel).

Males using AndroGel should talk with their healthcare professional about the viability of testosterone shots or, at a minimum, use extraordinary care not to expose women and children to AndroGel. For those who have any questions regarding AndroGel or its effects, contact Leigh O’Dell, a lawyer in our Mass Torts Section, at Leigh.Odell@beasleyallen.com or 334-269-2343.