The Endocrine Society announced that it feels additional safety studies are needed to evaluate the risks of Testosterone Therapy drugs, like AndroGel. According to the Endocrine Society, a recent study by Finkle , published online in PLOS ONE, suggests that the risk of myocardial infarction is increased in men who are receiving testosterone therapy and who have pre-existing heart disease. This report follows on the heels of another study from the Veterans Health Care System, which also found a higher frequency of death and cardiovascular events in men who had documented coronary artery disease and who were administered testosterone therapy.
In 2010, a randomized placebo-controlled trial of testosterone in older men with mobility limitation, funded by the National Institute on Aging (NIA), was stopped early by the trial’s data and safety monitoring board, due to the higher frequency of cardiovascular-related events in men assigned to the testosterone arm of the trial than in those assigned to the placebo arm. These studies have heightened concern about the safety of testosterone therapy in older men with pre-existing heart disease.
Many patients in the United States are being prescribed testosterone for the treatment of age-related symptoms or age-related decline in testosterone levels, for which testosterone therapy has not been approved by the Food and Drug Administration.
Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels. The NIA-funded T Trials, an ongoing randomized trial of testosterone in older men with unequivocally low testosterone levels and symptoms – sexual dysfunction, physical dysfunction or low vitality – will determine whether testosterone therapy improves these symptoms, and whether it is safe.
Until evidence from large randomized trials becomes available, the Endocrine Society believes 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. Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have pre-existing heart disease.
If you or a loved one have suffered a stroke, blood clot or heart attack while using a testosterone medication, like AndroGel, please call our experienced testosterone attorneys at (888) 606-5297 for a free consultation about your potential testosterone lawsuit.