AndroGel (Testosterone Topical) Transfer to Women and Children: When It Doesn't Go Away

What the label says happens after exposure ends

The prescribing information for testosterone gel 1% describes postmarketing reports of secondary exposure in children. In most cases, the signs and symptoms regressed after exposure to testosterone gel ended [1]. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age [1]. The label reports these outcomes without a timeline for how long the residual findings lasted [1].

The Teva label is not AndroGel's. It says topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure, and that testosterone gel 1% differs in dosage and administration from testosterone gel 1.62% [1].

Which signs are reported in children and in women

In children, the label lists enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age [1].

In adult women, it lists changes in body hair distribution, a significant increase in acne, and other signs of virilization as findings associated with possible secondary exposure [1]. It does not describe whether those signs persist.

The label says the risk of transfer was increased in some cases by not adhering to precautions for the appropriate use of the topical testosterone product [1].

What contact the label warns against

The boxed warning states that virilization has been reported in children who were secondarily exposed to testosterone gel, and that children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [1]. The warnings and precautions section extends the contact warning to women [1].

Pregnancy and secondary exposure

Testosterone gel 1% is contraindicated in women who are pregnant. The label says testosterone can cause virilization of the female fetus when administered to a pregnant woman, and that pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel. If a pregnant woman is exposed, the label says she should be apprised of the potential hazard to the fetus [1].

What the 2004 Pediatrics case series reported

A case series published in Pediatrics in 2004 described children who were virilized by contact with adults using cutaneous steroid preparations [2]. The parents were unaware of the danger of passive transfer, laboratory data were consistent with exogenous androgen exposure, each child had an opportunity for passive exposure, and discontinuation of contact resulted in a decrease in androgen levels or regression of symptoms [2]. It is a case series rather than a controlled trial, and its summary gives no resolution timeline [2].