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
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
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. Published online December 28, 2018179(3):446–448. doi:10.1001/jamainternmed.2018.6505
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: