AbbVie Inc.’s commercials promoting its AndroGel testosterone replacement therapy for so-called Low T piqued Jeffrey Konrad’s interest. The commercials claimed that low levels of the male hormone could hamper libido, cause weight gain, and reduce muscle mass. Men who suffered from these and other symptoms of Low T were encouraged to ask their doctors if they were candidates for testosterone therapy.
Konrad, of Tennessee, was intrigued enough to talk to his doctor and, in 2010, obtained his own prescription for AndroGel. Sixty-five days later, he suffered a heart attack. That’s when Jeffrey learned that testosterone treatments were intended for men with hypogonadism, a condition in which a man has low testosterone due to disease or injury. It was never meant for men with age-related hypogonadism.
Studies have even shown that testosterone treatment could increase the risk of heart attacks, strokes, blood clots and cardiovascular death. Yet, Konrad says, he was never warned by AbbVie that its top-selling testosterone gel could cause life-threatening injuries.
Jeffrey and his wife Jana are among 4,200 people who have filed suit against AbbVie and manufacturers of other testosterone replacement products alleging they were mislead about testosterone side effects. Lawsuits allege the companies aggressively marketed the drug for off-label uses. The Konrads’ case is the first to be tried, and is currently underway in an Illinois federal court. The case is expected to last three weeks.
In 2015, the Food and Drug Administration (FDA) required manufacturers of testosterone treatments to include new warnings on the safety labels of their testosterone treatments regarding an increased risk of blood clots, heart attacks and strokes, some of which have been fatal. The agency also tightened prescribing of the hormone to reduce prescriptions for age-related hypogonadism.
“The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone,” the FDA said in a Safety Announcement.