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On June 6, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all testosterone-replacement therapy lawsuits into one court in the Northern District of Illinois. Plaintiffs involved in this litigation typically claim that the drugs caused them to suffer cardiovascular effects, including heart attacks and strokes, and that the manufacturers of the drugs failed to provide adequate warnings as to the cardiovascular risks.

Plaintiffs may now have additional evidence to support their claims. According to a recent study published in Pharmacotherapy, there is an increased risk for heart attack among first-time users of testosterone replacement therapy.

Study Shows Significant Increase of Heart Attack Among First-Time Users

For the study, researchers looked at data for over 930,000 men aged 45-50, which was included in the IMS LifeLink Health Plan Claims Database. For each case of heart attack, they identified four controls, and then analyzed risk of heart attack before and after the start of a first-time prescription for testosterone replacement drugs.

Results showed that men who used these drugs for the first time were 40 percent more likely to suffer a heart attack than men who were not using the drugs.

Other Studies Show Similar Risks

Testosterone replacement drugs have been widely prescribed to men with “hypogonadism,” a medical condition that reduces levels of the testosterone hormone in the body. Prescriptions for men without such a medical condition, however, have increased over the past several years, with men requesting the drug because of low energy, reduced libido, loss of muscle mass, or other typical symptoms of aging.

Other studies have raised concerns over this trend. In January 2014, for example, PLoS One published research showing that in both older men and in younger men already diagnosed with heart disease, testosterone therapy could increase the risk of heart attack.

An earlier 2010 study also suggested that testosterone gel increased risk of adverse cardiovascular events among men with limitations in mobility and a high prevalence of chronic diseases like high blood pressure, diabetes, and high cholesterol.

These and other studies brought the concern to the FDA’s attention. The administration convened an expert panel to investigate the potential association between testosterone drugs and cardiovascular problems. They concluded in September 2014 that these drugs should not be used by men who are experiencing normal reductions in testosterone caused by aging, but only by men with diagnosed hypogonadism.

The panel also recommended additional studies on the drugs and their potential connection to strokes, heart attacks, and other cardiovascular issues.

Plaintiffs Seek Compensation in Testosterone Lawsuits

Plaintiffs seeking compensation from drug manufacturers for alleged testosterone-related cardiovascular events commonly state that the defendants overpromoted their products to the public, convincing men to ask their doctors about prescriptions before being diagnosed with true hypogonadism. They also claim that the defendants failed to include adequate warnings about the heart attack and stroke risks on their products.

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