Pharmaceutical giant AbbVie, Inc. has reported a 4.3 percent increase in its first-quarter profits, according to Nasdaq. The Chicago-based company cited heightened sales of anti-inflammatory medications, and detailed its plans to keep its top-selling drug Humira afloat.
Despite the rise in profits, AbbVie still faces financial trouble in the form of testosterone lawsuits. The company’s popular “low-T” product, AndroGel, is one of a handful or prescription testosterone treatments that have come under legal fire. Testosterone lawsuits have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Illinois. Currently, MDL 2545 includes well over 1,500 testosterone lawsuits, many of which target AbbVie.
Testosterone therapy drugs come in a variety of forms, from topical gel to pills. Popular brands include Androgel, Axiron, Fortesta, Striant, and Testim. Low-T products generate billions of dollars in sales annually, and it is estimated that over two million men use testosterone therapy products each year. Despite its popularity, however, testosterone therapy has been shown to pose serious health risks. A study published in November 2013 linked testosterone therapy to increased rates of heart attack, stroke, and death. Another study in 2014 found that men who received testosterone therapy were significantly more likely to suffer myocardial infarction—especially those aged 65 years or older.
In January 2014, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning of a potential link between testosterone therapy products and cardiovascular problems. Later that year, the FDA released a statement that all testosterone therapy products on the market must include a warning about the general risk of blood clots. The agency has also had to crack down on off-label use of testosterone, reminding consumers and producers alike that testosterone therapy is only approved for use in “men who have low testosterone levels due to disorders of the testicles, pituitary gland or brain that cause a condition called hypogonadism.”
Over 100 new testosterone lawsuits have been added to the MDL since the beginning of May, and the total number of cases is expected to continue growing.