Study’s Findings Question Link Between Testosterone Drugs and Blood Clots

Concerns over heart attack and blood clot side effects of testosterone therapy previously resulted in thousands of lawsuits against drug manufacturers.

A new study has raised doubts about prior findings that suggested men using testosterone replacement therapy (TRT) may face an increased risk of developing blood clots in men, indicating that more research is needed to confirm the potential side effects.

In findings presented at the annual scientific meeting of the Sexual Medicine Society of North America this week, researchers suggested that TRT supplementation does not cause an effect on the coagulation system in men that may increase the risk of developing deep vein thrombosis (DVT).

Treatments for low testosterone were initially intended as a “niche” treatment, for men who experienced drops in testosterone levels associated with a condition known as hypogonadism. However, amid aggressive drug marketing in recent decades, which encouraged men to talk to their doctors about a non-existing medical condition referred to as “low T”, many men sought the treatments when they were not medically needed, to treat symptoms associated with natural drops in testosterone associated with aging.

Over the past decade, a number of different studies studies have warned about the potential side effects of testosterone replacement therapy in men, suggesting the use of the medication may cause increased risk of blood clots, regardless of whether they have been diagnosed with hypogonadism that the medications are designed to treat.

However, in the study presented at this week’s conference, Dr. Eduardwil Hernandez-Vegas, a research fellow at the University of Utah in Salt Lake City, and colleagues, presented findings which tracked 1.85 million men with hypogonadism for 12 months to determine the rate in which they suffered deep vein thrombosis.

The results of the study indicate there was no significant difference in the rate of DVT development between men with hypogonadism, finding 34.96% of those treated with TRT developed DVT, while 33.04% not treated with TRT still developed DVT.

Although Hernandez-Vegas stated the findings of the study should not be considered conclusive, the study suggests men with hypogonadism who developed blood clots were not more likely to have recently been on testosterone-replacement therapy. The study’s findings are considered preliminary until published in a peer-reviewed journal.

From 2001 to 2013, prescriptions for testosterone drugs increased more than 300%. However, following studies that highlighted the potential risk of heart attacks, strokes and blood clots associated with testosterone therapy, the U.S. Food and Drug Administration (FDA) issued warnings about their overuse, and prescriptions have dropped in recent years.

Following continuing concerns about the side effects of testosterone treatments, the FDA ordered a label change for all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams patches and injections after concluding there is evidence of a possible link between testosterone drugs and heart problems.

Over the last several years, thousands of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other claims have been filed against manufacturers of testosterone therapy, indicating that they recklessly marketed the drugs and failed to adequately warn about the potential risks. Most manufacturers have reached testosterone settlements to resolve nearly all pending claims.