The Endocrine Society has issued a statement highlighting the need for robust evaluation of the risks associated with testosterone therapy (TT). In it, the Society recommends that “patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms.”

Furthermore, the Society believes that “it may be prudent not to administer testosterone therapy to men who have had a cardiovascular event (such as myocardial infarction, stroke or acute coronary syndrome) in the preceding six months.” The recommendations are prompted by recent studies suggesting that TT is associated with an increased risk of cardiovascular problems (such as heart attacks), stroke, and death.

The statement also notes that numerous patients in the US have had TT for “treatment of age-related symptoms or age-related decline in testosterone levels” and that such use “has not been approved” by the Food and Drug Administration. The Endocrine Society stresses the need for “[l]arge scale, prospective, randomized controlled trials [in order] to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels.”