Concerns about testosterone side effects have led the U.S. Food and Drug Administration (FDA) to discourage use of testosterone therapy for anything other than actual medical conditions.

The federal agency issued a Drug Safety Communication in January 2014 announcing that it had begun to investigate the risks of certain cardiovascular conditions associated with testosterone therapy.

Two different studies had gotten the agency’s attention by showing an increased incidence of stroke, heart attack and death in men who had used testosterone replacement products.

The first study reviewed the experiences of older male patients in the U.S. Department of Veterans Affairs health care system who were having cardiovascular imaging studies done.

Some of these men received testosterone replacement therapy while others did not. The results of this study suggested the men who received testosterone products had a 30 percent increased risk of stroke, heart attack or death.

The second study cited by the FDA reviewed results from both older and younger men who had been prescribed testosterone therapy. In the first 90 days after beginning therapy, men age 65 and older showed twice the risk of heart attack. Young men with a history of pre-existing heart disease showed a two- to three-fold increase in risk during the same period.

Testosterone Products Not Approved to Treat Natural Aging Processes

In March 2015, the FDA followed up with a second communication warning against using testosterone replacement therapy as a treatment for low testosterone levels not associated with any actual medical condition.

The federal agency said they had become aware of a trend in the use of these products as a treatment for symptoms in men who have no particular cause of low testosterone other than aging.

The FDA pointed out that no testosterone products have been approved to treat the reduction in testosterone that occurs naturally with aging, and that they had not yet evaluated the safety and efficacy of testosterone products as treatments for low testosterone in the absence of some associated disease.

With that communication, the FDA also announced it was mandating changes in the labeling of testosterone products to better reflect the risks of heart attacks and strokes associated with testosterone replacement therapy.

The FDA reiterated its concerns in an August 2015 article published in the New England Journal of Medicine. The article expresses concern for the use of testosterone to treat what it calls “age-related hypogonadism” or “late-onset hypogonadism” – both referring to the natural decrease in testosterone that comes with age, and neither of which is necessarily pathological.

The agency then announced that they were requiring testosterone product manufacturers to conduct a controlled clinical trial to assess the effects of testosterone therapy on cardiovascular health.

This trend in the use of testosterone for what is essentially a “lifestyle drug” arose simultaneously with promotional campaigns that pharmaceutical manufacturers ran to promote the use of testosterone products as a treatment for what the manufacturers refer to as Low-T, or simply low testosterone.

The marketing materials encourage men to ask their doctors about testosterone products if they are experiencing symptoms that are actually associated with the natural decrease in testosterone that occurs with aging.