Shortly after the FDA’s January 2014 statement that it plans to evaluate the safety of testosterone therapy, the national Endocrine Society has called for large-scale randomized trials to fully evaluate the risks of testosterone therapy.
Both organizations are calling for action in the wake of three recently published studies which found a higher rate of cardiovascular events (including heart attacks and strokes) in men who received testosterone and had preexisting heart problems.
Testosterone is approved for the treatment of hypogonadism, the clinical term for low testosterone. One study found 25% of the participants had not had their testosterone serum levels tested prior to a prescription being provided and suggested that the drug was prescribed based primarily on patient complaints of symptoms such as low energy and libido.
Additional data on the safety risks associated with testosterone is also expected shortly from an ongoing randomized trial conducted by the National Institute on Aging. This trial will evaluate the effects of testosterone in about 800 older men with low testosterone levels who display muscle weakness, fatigue, and low libido among other symptoms. This trial will be track cardiovascular events of participants and offer important insight for patient safety information involving testosterone therapy drugs.
In the meantime, men who are considering testosterone therapy should consult with their doctors about potential cardiovascular risks. According to the Endocrine Society, men who have had a cardiovascular event in the preceding six months should not take testosterone supplements.