AndroGel, a testosterone replacement drug manufactured by Abbott Laboratories and its spin-off company AbbVie Inc., is the subject of several lawsuits filed in the U.S. District Court for the Northern District of Illinois. The plaintiffs in the cases allege that AndroGel increased the risk of heart attack, stroke and blood-clot related injuries. One of the most recent cases, filed on February 10th, was filed on behalf of a man who suffered from deep vein thrombosis and a pulmonary embolism after using AndroGel multiple times.
Deep vein thrombosis is when a blood clot forms in a deep vein of the body, oftentimes the legs. Pulmonary embolism is a potentially life-threatening situation where this clot breaks loose and causes a blockage in the lung. The February 10th lawsuit alleges that AndroGel increases the risks of deep-vein thrombosis and pulmonary embolism by increasing hematocrit levels, which thickens the blood.
Five other cases were filed on February 4th. The plaintiffs were all between the ages of 50 and 63. Three of these men suffered from a heart attacks, allegedly due to AndroGel. A fourth alleges that the product caused a stroke and the fifth says he suffered from a mini-stroke. Abbott and AbbVie are accused of misrepresenting AndroGel; the product was promoted by retired professional athletes but the risks were not fully stated, the suits allege.
Testosterone therapy drugs are only approved for men who actually have low levels of the hormone due to a medical condition. An increasing number of men, however, have been taking testosterone to treat symptoms of “low-T”, which include symptoms of aging such as fatigue and low sex drive. Experts have expressed concerns that men are exposing themselves to heart risks by taking testosterone replacement therapy that they do not need.
Late last month, the U.S. Food and Drug Administration (FDA) said it was reviewing the risks of stroke, heart attack and death associated with the use of testosterone drugs. The review is being conducted after two studies indicated increased heart risks in men who take testosterone therapy. In January, a study in PLoS One, found that testosterone therapy doubled heart risks in older men with no history of heart disease and triple the risk in younger men who did have a history of heart disease. Last November, the Journal of the American Medical Association (JAMA) found a 30 percent increased risk of stroke, heart attack and death in men who used testosterone therapy compared to those who did not; many of the men in that study had underlying heart problems.