January 7, 2015 — The number of lawsuits involving testosterone replacement products like Axiron has nearly reached 300, with two new cases filed this week.
About 295 cases are now pending in the U.S. District Court for the Northern District of Illinois, where the litigation has been centralized since June 2014.
Most of the lawsuits are filed against AbbVie, AndroGel (testosterone gel). Plaintiffs accuse drug-makers of failing to warn about evidence linking testosterone therapy with cardiovascular side effects like heart attack, stroke, and blood clots.
One example is a lawsuit that was filed in October on behalf of James A. Foley, a 70 year-old man who started using Axiron in 2011 to treat symptoms he attributed to “Low T.” The following year, he was hospitalized with a blood clot in his legs (deep vein thrombosis) that traveled to his lungs, causing a life-threatening pulmonary embolism.
Evidence linking testosterone products like Axiron with blood clots has been growing for years. One of the first studies to find a risk was halted prematurely after older men in poor health on testosterone had more cardiovascular events than similar men who did not take testosterone.
In April 2014, the FDA opened an investigation into two studies. One study found evidence of a 30% increased risk of heart attack, stroke, and death among older men. Another study found that men over 65 on testosterone were twice as likely to have a heart attack.