Testosterone products have been approved in the United States for over 50 years. In 2009, slightly more than 2.4 million men received prescriptions for testosterone replacement therapy (TRT) and by 2013, that number had more than doubled to 5.6 million men. Popular though they may be, testosterone products are accompanied by conflicting reports of safety, with some (only some) studies providing data of increased risk of heart attacks and other serious drug reactions. The Food and Drug Administration (FDA) has planned an advisory panel meeting on Sept. 17 to better understand whether testosterone products are truly useful — and safe — for men.

Why use testosterone products?

Drug therapy is prescribed most often to treat hypogonadism, an endocrine disorder characterized by deficient or absent testosterone levels. Accompanying symptoms may include impaired sexual function, hair loss, abdominal obesity, insomnia, muscle wasting, decreased strength, reduced bone mineral density, and regression of secondary sexual characteristics. Men begin to experience a decline in their levels of sex hormones, much like women, in their 40s.

Guidelines for the evaluation and treatment of all androgen deficiency syndromes in adult men have been established by the Endocrine Society. Recommendations include confirmatory testing of low testosterone levels before treatment and ongoing evaluation throughout treatment. However, in its examination of TRT trends, the FDA found one quarter of all patients had never been lab tested for their testosterone levels before their first prescription for a testosterone drug, while 21 percent of patients had never been lab tested during their treatment period. 

Meanwhile, primary care physicians, not endocrinologists, have taken the lead as the most frequent prescribers of testosterone products, accounting for about 60 percent of all prescriptions. According to FDA briefing materials, data suggest sexual function complaints rank among the most common reasons men seek treatment. While men between 45 and 64 received the highest number of prescriptions (about 60 percent), men younger than 45 years constitute 19 percent of all prescriptions and men over 65 make up 21 percent. However, between 2009 and 2013, the younger age categories showed the greatest increase in drug prescriptions, with a 230 percent uptick for men under 25 in addition to a 282 percent and 262 percent surge for men between 26 and 34, and those between 34 and 44, respectively.

In July, The Wall Street Journal reported Health Canada requested updated product labeling for testosterone drugs after their review of published reports indicated a risk of heart attacks and other serious reactions. Only now is the FDA addressing the issue through an advisory panel meeting, though the agency appears less inclined than Health Canada to change its previous rulings. “Product labeling, for TRT, characterizes current knowledge of CV risk," the FDA noted in the briefing materials for its upcoming meeting. "A thorough review of the available TRT literature found insufficient evidence to support an association between testosterone use and an increased risk of CV events. However, the TRT Sponsors also recognize continued active surveillance is required given the questions raised, particularly in certain subpopulations, such as elderly men and/or patients with preexisting CV disease.”

According to Drugwatch, American men are spending $2 billion on testosterone drugs each year, with economists estimating sales reaching $5 billion by 2017. FDA may be content to wait for ongoing research to provide additional information as to the benefits of testosterone use in older men and “relevant information on safety,” but individual patients do not have to wait for further scientific studies. Certainly, they can decide for themselves the wisdom of replacement therapy for a condition many would consider to be a natural part of aging.