According to recent data from the U.S. Judicial Panel on Multidistrict Litigation, the number of testosterone therapy lawsuits pending in federal court has climbed to 3,238. The Illinois multidistrict litigation, established in June 2014, initially included just eight testosterone lawsuits.
Popular Low-T drugs like AndroGel, Axiron, and Testim are approved by the U.S. Food and Drug Administration (FDA) for use in men whose testosterone is low due to a medical condition known as hypogonadism. In other patients, however, such as men whose testosterone has dropped naturally due to aging, the benefits of testosterone therapy are not considered to outweigh the risks. These risks, as outlined in two 2014 safety communications from the FDA, include several severe cardiovascular problems, such as stroke. Additional studies found that testosterone replacement drugs increased users’ risk of heart attack, especially in men 65 years or older.
Men who have filed testosterone therapy lawsuits claim that companies like AbbVie and Eli Lilly promoted their products for off-label use, targeting otherwise healthy men who were unhappy with their diminished sex drive. However, as many men have found out, Low-T drugs are not the sexual remedy they are often advertised to be. Recently, the FDA stated testosterone drug manufacturers would have to provide more convincing evidence of their products’ safety before the agency approved them for lifestyle use.