Side Effects of Testosterone Therapy May Increase Short-Term Blood Clot Risk Among All Men: Study

New research suggests that all men face an increased risk of suffering blood clots from testosterone therapy, regardless of whether they have been diagnosed with hypogonadism that the medications are designed to treat.

In a study published this week in the medical journal JAMA Internal Medicine, researchers indicate that men who take hormone therapy testosterone face double the risk of suffering a deep vein thrombosis or pulmonary embolism, including both situations where use of the drugs is medically indicated and when it is not.

The blood clot risk associated with side effects of testosterone therapy was also seen among all age groups, although there was some evidence that the association was more pronounced among younger men, leading researchers to indicate doctors should exercise caution when prescribing drugs like Androgel, Axiron, Testim and other treatments.

In the study, researchers from University of Minnesota School of Public Health conducted a case-crossover examination of health records data for nearly 40,000 men from the IBM MarketScan Commercial Claims and Encounter Database and the Medicare Supplemental Database from January 1, 2011, to December 31, 2017. The study included men who had hypogonadism, a condition in which the body doesn’t produce enough testosterone, and men who did not have the condition. Roughly 8% of men enrolled had diagnosed hypogonadism or low levels of testosterone.

Researchers included men who were cancer free at the beginning of the study and had 12 months of continuous enrollment before having a venous thromboembolism event. Venous thromboembolisms include deep vein thrombosis, a type of blood clot in the body, or pulmonary embolism, which is when a blood clot breaks free and travels to the lungs blocking the blood supply. Both are life threatening conditions.

Side effects of testosterone therapy was linked to a higher risk of blood clots in men with and without hypogonadism. Men with the diagnosed low-testosterone condition faced double the risk of blood clot, while those without diagnosed low-testosterone had 2.3 times the risk.

Men under 65 years old faced an even higher risk. Their risk was three times higher if they did not have low testosterone and 1.5 times higher if they had low testosterone, but were younger than 65.

The findings should help men to rethink requesting a testosterone prescription from their doctor to treat symptoms that are typical of aging.

Treatments for low testosterone, commonly referred to as “low T” in drug advertisements, grew in popularity over the past few decades, resulting in many men taking the drugs when there is no diagnosis of hypogonadism or medical indication for the treatments.

Amid aggressive advertisements by the pharmaceutical industry, prescriptions for testosterone increased more than 300% from 2001 to 2013, as more men requested the hormone treatment from their doctors to address symptoms associated with natural drops in testosterone as all men age. However, after the FDA first warned about the blood clot, heart attack and stroke risks associated with testosterone therapy, prescriptions have dropped in recent years.

In recent 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. Testosterone settlements have been reached by most major manufacturers to resolve nearly all pending claims.