Signals of cardiovascular risk from off-label prescription testosterone use began with the early termination of a placebo-controlled trial in frail, older men. Basaria et al1 revealed more cardiovascular events among men randomized to receive testosterone than among men randomized to receive placebo. Some observational studies reinforced these concerns for cardiovascular risk.2,3 In 2014, the US Food and Drug Administration (FDA) issued a safety communication about testosterone drugs, and the Endocrine Society expressed particular concern about testosterone use by men with heart disease.4,5 In 2015, the FDA revised testosterone labels, highlighting the lack of efficacy evidence for age-related hypogonadism and adding a warning about possible increased cardiovascular risk.6
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Morden NE, Woloshin S, Brooks CG, Schwartz LM. Trends in Testosterone Prescribing for Age-related Hypogonadism in Men With and Without Heart Disease. JAMA Intern Med. 2019;179(3):446–448. doi:10.1001/jamainternmed.2018.6505
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