Case Info
AndroGel is a topical gel formulation of testosterone replacement medication intended to be applied to the skin daily. It is approved to treat low testosterone levels associated with primary hypogonadism which can cause low testosterone levels. Though it can be used as an “off-label” treatment, manufacturers cannot promote their products for unapproved reasons. AbbVie and other manufacturers were accused of marketing their products for “Low-T,” an unapproved use.
“Low-T” advertising implied that decreasing testosterone levels is responsible for normal symptoms of aging and encouraged the use of AndroGel and other medications to increase energy levels and sex drive and to restore muscle tone. Declining testosterone levels are a natural function of aging and many of the men who used AndroGel for “Low-T” never had their testosterone levels tested, which placed them at unnecessary risk for life-threatening side effects.
In 2014, the Food and Drug Administration (FDA) issued a warning to consumers about the potential risk of AndroGel and other testosterone replacement therapy. The announcement warned that men who use testosterone replacement may have a two- or three-fold increase in the risk for blood clots, which can result in stroke or heart attack.