Large-Scale Scientific Studies Needed for "Low T" Treatments

The Endocrine Society released a statement last week that claimed large-scale scientific studies are required to better understand the side effects of testosterone therapies such as AndroGel, Fortesta and Testrim. The society noted that while two recent studies have linked low testosterone treatments to an increased risk of heart attack, stroke and death, more studies are needed to determine the true risks and benefits of these “low T” medications.

The Society’s statement{:target="_blank"} stressed the importance of large-scale, randomized controlled trials, which would help determine the risks and benefits associated with these treatments – especially in men who are experiencing low levels of testosterone due to age.

While recent studies show that prescription testosterone may be linked to cardiovascular problems, the Endocrine Society stated that a small, prospective randomized trial, as well as one database analysis, found that men using testosterone therapies actually reported fewer cardiovascular events; however, the Society noted that retrospective database analyses are limited by their “inherent inability to verify the indication for treatment, diagnoses, or other relevant quantitative information.” The Society stressed that this information is particularly important, as many men in the United States are prescribed testosterone for unapproved uses, such as the treatment of age-related symptoms and low testosterone levels caused by aging.

The Society said there are ongoing randomized trials, known as the T Trials, that may determine whether testosterone therapy is safe and actually treats symptoms of “low T,” such as sexual dysfunction, physical dysfunction or low vitality. In the meantime, the Society suggested that patients talk to their doctors about the risks and benefits of using prescription testosterone, particularly those who have pre-existing heart conditions.

The Endocrine Society’s statement came just days after the FDA announced that it would be investigating the safety of testosterone therapies. In its safety announcement, the agency cited the same two studies referenced in the Endocrine Society’s statement. Both studies found that men who used prescription testosterone were at a higher risk for heart attack, stroke and death.

In light of this information, the attorneys at Morgan & Morgan have begun investigating potential lawsuits on behalf of men who used prescription testosterone products and suffered from heart attacks or strokes.