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Secondary exposure to testosterone from patients receiving replacement therapy with transdermal testosterone gels

Accepted: 19 December 2011; published online: 20 January 2012 Citation: Curr Med Res Opin 2012; 28:267–69 The potential for unintended transfer of testosterone to others from adult men receiving transdermal testosterone gel treatment for hypogonadism is a recognized safety concern, due to the undesirable pharmacologic ffects of testosterone in women and children. The following three papers present the results from five phase 1 studies that investigated the transfer of testosterone to adult women from male partners who applied a 1.62% testosterone gel (AndroGel 1.62%, Abbott). There are four gel products currently marketed in the United States for testosterone replacement therapy in hypogonadal males: AndroGel 1%, AndroGel 1.62% (Abbott, North Chicago, IL), Testim (Auxilium Pharmaceuticals, Malvern, PA), and Fortesta (Endo Pharmaceuticals, Chadds Ford, PA). In addition a 2% topical solution is available (Axiron, Lilly, Indianapolis, IN). These products are applied topically and deliver testosterone to increase serum concentrations to eugonadal levels in men with low testosterone levels. Testosterone gels are applied daily to the skin of the upper arms/shoulders and/or abdomen, or thighs of male patients, depending on their dosing instructions. Since only a low fraction of testosterone is absorbed transdermally from the gels, there exists a significant reservoir of steroid on the surface of the skin, and this residual testosterone could be transferred to others who come into direct skin contact with the patient’s site of gel application. Transfer of testosterone to women or children via skin contact with the application site following gel application has been reported. Even small quantities of testosterone transferred on a repeated basis to these individuals may result in the clinical signs and symptoms of hyperandrogenism, sexual precocity, or inappropriate virilization. The signs and symptoms of secondary testosterone exposure in children include the development of pubic hair, enlargement of the penis or clitoris, increased number of erections and libido, advanced bone age, and aggressive behavior. Usually these signs regress once the testosterone source is removed, although there are instances when the genitalia do not completely return to normal size, and bone age remains slightly greater than chronological age. The signs and symptoms of testosterone exposure in women are the development of acne, changes in body hair distribution or other signs of virilization, or menstrual irregularity. Testosterone product labeling states that testosterone is teratogenic and may cause fetal harm. Fetal exposure to androgens can cause virilization, so testosterone exposure should be particularly avoided during pregnancy. The United States Food and Drug Administration (FDA) addressed the issue of testosterone gel safety in May 2009. It reported the receipt of eight reports of secondary exposure to testosterone in children ranging in age from 9 months