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Testosterone Side Effects: Researchers Looking for Answers

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Los Angeles, CAWith conflicting and confusing research surrounding testosterone side effects, including testosterone lawsuits alleging patients suffered serious health problems after using testosterone, it can be difficult for patients to know whether or not the risks are worth the benefits. Studies conducted so far offer conflicting results, with some critics asking that studies be pulled. Meanwhile, lawsuits filed against testosterone makers have been consolidated for multidistrict litigation.

The Los Angeles Times (4/28/14) reports that almost three percent of American men over the age of 40 take prescription testosterone. They rely on the medical advice of their doctors, who rely on studies and warning labels to let them know about the risks associated with a particular drug. With testosterone, the risks are not altogether clear. Some studies have suggested a link between the use of testosterone and heart problems, but not everyone agrees on the credibility of those studies.

One study, published in JAMA (Journal of the American Medical Association, 11/13), suggested a link between testosterone and an increased risk of heart attack and stroke. But critics note there are serious concerns about the study, including that the study size was smaller than noted.

Doctors and researchers have called for more research to be done into the issue. The Endocrine Society (2/7/14) released a statement encouraging more research be done examining the risk of cardiovascular events in men who receive testosterone therapy.

“Until evidence from large randomized trials becomes available, the Endocrine Society believes that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels,” the society writes. Specifically, the organization wants large-scale, prospective, randomized, controlled studies.

According to the Endocrine Society, one study was stopped early because of the higher rate of cardiovascular-related events in men who were assigned to the testosterone group than those assigned to the placebo group. That study was funded by the National Institute on Aging (NIA) and halted in 2010.

While researchers attempt to sort out the risks associated with testosterone, lawsuits have been consolidated for pre-trial multidistrict litigation (MDL No. 2545). Those lawsuits were consolidated in U.S. District Court, Northern District of Illinois. The lawsuits allege men who used testosterone drugs, including AndroGel and other similar products, suffered serious cardiovascular events.

In consolidating the lawsuits, the panel on multidistrict litigation noted that all actions involve patients (or their survivors) who used testosterone therapy and allege that the use of testosterone drugs caused injuries including heart attack, stroke, deep vein thrombosis and pulmonary embolism.

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