Morden NE, et al. - In men with and without heart disease, researchers studied trends in testosterone prescribing for age-related hypogonadism. Signals of cardiovascular risk from the use of off-label prescription testosterone began with the early completion of a placebo-controlled trial in frail, older men. The US Food and Drug Administration (FDA) issued a safety communication about testosterone drugs in 2014 and the Endocrine Society voiced specific concern about men with heart disease using testosterone. The FDA revised testosterone labels in 2015, stressing the absence of evidence regarding efficacy for age-related hypogonadism and warning about a possible increase in cardiovascular risk.