Testosterone gel transfer to children prompts FDA boxed warning
This article was originally published in Scrip
Executive Summary
The US FDA has ordered that "black box" warnings be added to two testosterone replacement gel products, Solvay's AndroGel 1% and Auxilium Pharmaceutical's Testim 1%, after receiving reports of adverse effects in children inadvertently exposed to the hormone through contact with another person being treated with these products who had not adhered to the labelled precautions. Young children exposed to the product experienced adverse effects in growth and inappropriate virilisation, such as male sex characteristics in young girls or premature development of male sex characteristics in young boys.