Just days after the Food and Drug Administration (FDA) announced it was investigating the safety of testosterone replacement treatments, the U.S. Endocrine Society called for a fuller assessment of the risks and benefits associated with the hormone treatment.
The actions follow two new studies that raised serious concerns about the risks of testosterone therapy in older men. One study showed that men who used testosterone supplements were significantly more likely to have a heart attack in the first 90 days after starting the treatment. A second study found that older men who used the treatment were nearly 30 percent more likely than men not taking the supplements to have a heart attack, stroke, or die of any cause.
A third study, which began in 2010 and focused on men with mobility issues, was halted prematurely after trial data showed a higher frequency of cardiovascular-related events in men using testosterone supplements compared to men given a placebo.
Testosterone replacement therapy is used in men who have low levels of the hormone due to diseases of the testes, pituitary and hypothalamus. However, heavy marketing campaigns waged by drug companies pushing testosterone treatments, such as AndroGel, Testim, and Axiron, have encouraged many men to ask their doctors if they have “Low T.”
Most men, as they age, experience a drop in testosterone, which can lead to a diminished sex drive, weight gain and fatigue. The supplements can help boost libido and increase muscle mass. As a result, sales of testosterone supplements have skyrocketed in the past decade, leading many to wonder if most men prescribed the supplements actually need them.
The Endocrine Society maintains that testosterone therapy is generally safe and beneficial when used to treat young men with low testosterone levels who are exhibiting symptoms. However, they say that prescribed testosterone therapy should be accompanied by a standardized monitoring plan to optimize the dose and minimize the risk of adverse effects.