The number of prescriptions for testosterone replacement therapy for men 40 years of age and older has risen 300 percent between 2001 and 2011, and a quarter of the most recent testosterone therapy users have never had their blood levels checked to determine if the need the medication, according to a study published in JAMA Internal Medicine.
The research was spearheaded by Jacques Baillargeon, an epidemiologist at the University of Texas Medical Branch in Galveston, who wondered if the increase in advertising for testosterone treatments was resulting in an increase in prescriptions for the drugs. The ads offered relief from symptoms of low testosterone, such as low sex drive, muscle loss, weight gain and fatigue, and encouraged men to ask their doctors if they were candidates for “Low T.”
Testosterone supplements, such as the brands AndroGel, Axrion and Testim, are intended for men who have a condition known as hypogonadism, a condition in which a man is unable to produce normal levels of testosterone, which is defined as 300 to 1,000 nanograms per deciliter of blood. Testosterone naturally lowers as men age, and blood tests are used to determine if a man needs testosterone replacement therapy.
To determine if the ads were prompting men to ask their doctors for the treatment, Baillargeon checked medical literature and pharmaceutical sales data and discovered that prescriptions for testosterone treatments were skyrocketing. About three percent of men in their 40s and nearly 4 percent of men in their 60s were taking some type of testosterone replacement therapy.
Could so many men have hypogondalism? The answer to that question proved to be another surprise. Baillargeon found that only half of the men receiving testosterone therapy during the study period tested positive for the condition. Another 25 percent undergoing testosterone therapy never had their testosterone levels checked.
“I don’t know what exactly is happening in the clinic visit, but to prescribe this treatment without accessing a baseline testosterone level, and to see that it is happening among 25 percent, is concerning, particularly since we don’t know the long-term risks of this,” Baillargeon said.
Earlier this year, the Food and Drug Administration (FDA) set out to better define the risks associated with testosterone therapy. The safety review was based on recent studies, which linked the treatment to an increased risk of heart attacks, strokes and death. In June, with the review still underway, the agency issued a warning that testosterone use had been associated with an increased risk of life threatening blood clots.
As a result, thousands of lawsuits have been filed against makers of testosterone treatments alleging the drug companies knew the risks with the hormone treatments but failed to warn doctors or patients, choosing instead to sink millions of dollars into advertisements promoting their testosterone treatments.