Pharmaceutical

Man blames testosterone product for disabling stroke

androgel pump 435x435 Man blames testosterone product for disabling stroke  Brian DeMatteo was the kind of guy who was always out playing tennis or surfing. But the 64-yer-old Boston businessman says it’s impossible to live that life after he suffered a spinal stroke in 2012 that left him in a wheelchair with chronic pain. He blames his injury on the testosterone replacement therapy AndroGel, and says its maker, AbbVie, is to blame for aggressively marketing the drug to men as a fountain of youth.

DeMatteo is one of about 4,200 men who have filed lawsuits against AndroGel and other manufacturers of testosterone treatments for off-label marketing of the medication for an alleged made-up condition they called Low T, and for not adequately warning of testosterone side effects. They say studies show that testosterone replacement treatments can increase the risk of heart attacks, strokes, blood clots and cardiovascular death.

The first bellwether trial involving cardiovascular risks with testosterone treatments began this week. It involves the case of Tennessee man Jeffrey Konrad who claims he suffered a heart attack about two months after starting treatment with AndroGel.

Testosterone therapy is intended for men with hypogonadism, a condition in which the body does not produce enough of the male hormone due to injury or disease. It is not intended for men with age-related hypogonadism. The Food and Drug Administration (FDA) has warned that there is no information backing up the benefits or safety of such use.

In 2015, the FDA also required testosterone manufacturers to update the labels on their testosterone products to include the potential increased risk of heart attacks, strokes, blood clots, and death with use of testosterone therapy.

DeMatteo’s trial date has not been set, but will likely be impacted by the outcome of Konrad’s trial as well as the remaining bellwether trials.

Source: Bloomberg