Testosterone Replacement Therapy (“Low-T”)
Testosterone replacement medications are approved for the treatment of low testosterone due to hypogonadism, chemotherapy or testicular damage. However, manufacturers are promoting the medications as an appropriate treatment to combat the natural aging process in men.
“Low-T” drugs are routinely prescribed off-label to help improve sex drive, strengthen bone density and build muscle mass. Testosterone is most often administered as a gel, patch or injection. Low-T drugs include Androgel, Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, and Testopel.
Multiple epidemiology studies have shown that testosterone drugs are associated with serious cardiovascular risks. Research conducted by the National Cancer Institute revealed that some men have a more than double the risk of suffering heart attacks while using testosterone replacement therapy.
Another study published in the Journal of the American Medical Association (JAMA) had similar results, finding that older men had a 29% increase in stroke, heart attack and death when undergoing testosterone therapy.
Additionally, a 2009 federally-funded study to address whether testosterone could help men build muscle had to be stopped because study participants were suffering heart attacks and other cardiac problems at an alarming rate.
On January 31, 2014, the United States Food and Drug Administration (FDA) announced it would begin investigating the cardiovascular safety profile of testosterone products. The FDA also required testosterone manufacturers to begin conducting their own safety studies on their products. However, it was not until later in 2014 that a warning regarding the risks of heart attack, stroke, pulmonary embolism, deep venous thrombosis and sudden death was added for the first time to the prescribing information for some testosterone replacement drugs.
On March 3, 2015, the FDA released a second Drug Safety Communication warning that testosterone is being used extensively off-label to offset the natural aging process. The FDA is now mandating that the label for all testosterone drugs warn about the risk of cardiovascular injuries.
Testosterone Replacement Therapy Litigation & Trial Update
In February 2014, five plaintiffs filed the first testosterone lawsuits against Abbott Laboratories and AbbVie, Inc. over injures suffered from their testosterone replacement drugs in the United States District Court for the Northern District of Illinois.
In March 2014, a motion was filed with the Judicial Panel on Multidistrict Litigation to consolidate all testosterone lawsuits filed in federal court to a federal court located in Illinois. The multidistrict litigation (MDL) was established in June 2014 before the Honorable Matthew Kennelly in the United States District Court for the Northern District of Illinois. The action, In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545, currently involves over 1,300 cases against multiple defendant manufacturers of testosterone replacement therapy products. Cases in the MDL are currently undergoing coordinated discovery.
If you or a loved one used a testosterone replacement therapy product and suffered a heart attack, stroke, pulmonary embolism, deep venous thrombosis, death or other cardiovascular injury, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.