Low T Lawsuits
In January 2014, the U.S. Food & Drug Administration (FDA) announced it would begin investigating the risk of serious events, including stroke, heart attack, and even death in men taking testosterone therapy products, such as:
The FDA’s investigation was prompted by the publication of two research studies that linked the use of testosterone replacement therapy to these events. In November 2013, a study conducted by researchers from the Veteran Affairs Eastern Colorado Health Care System in Denver was published in the Journal of the American Medical Association (JAMA). This study reported findings of a potential risk of heart attack, stroke and death in users of testosterone replacement treatments. The study also found that cardiovascular events occurred at a rate of 25.7 percent in men using testosterone therapy drugs, compared to a rate of only 19.9 percent in those who did not.
The National Cancer Institute also conducted a study of more than 55,000 men who had low testosterone levels and found that some men using testosterone replacement therapy were at an increased risk of suffering heart attacks and other cardiac related problems. The findings of this study were published in January 2014 in the PLOS ONE medical journal. This study also found that men over the age of 65 who were being treated for low testosterone levels had double the risk of a heart attack. For men with a prior history of heart disease, their risk tripled.
In June 2014, the FDA required manufacturers to include a general warning about the risk of venous thromboembolism, also known as blood clots in the veins, which include deep vein thrombosis and pulmonary embolism. The FDA required the change be applied to the labeling of all testosterone products in order to provide a general warning regarding these blood clots.
One year later, on March 3, 2015, the FDA required testosterone product labels be updated to include information on the increased risk of heart attacks and strokes in patients using testosterone related therapy.
Federal lawsuits against the makers of testosterone therapy products have been consolidated in the U.S. District Court for the Northern District of Illinois. Hundreds of cases have been filed against manufacturers of testosterone replacement therapy manufacturers by men who suffered strokes, heart attacks, and/or serious blood clotting events.
Testosterone Therapy Side Effects
While testosterone therapy products have not been recalled, studies have reported an association between the use of testosterone products and the risk of cardiovascular disease and thrombotic (blood clotting) events, including:
- Heart attack
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
Research Prompts FDA Investigation
Along with the PLOS ONE and JAMA studies, other research studies prompted the FDA’s investigation into testosterone therapy. In 2013, a study published in the Journal of Clinical Endocrinology and Metabolism revealed that testosterone therapy had increased among older men, though some patients did not meet the requirements for treatment.
A different study published in the Journal of American Medical Association revealed that 25 percent of testosterone therapy users did not have their testosterone levels measured prior to beginning usage of Low-T therapy.
In the FDA’s 2015 safety announcement, the Administration noted that testosterone therapy should only be prescribed to men with low testosterone levels caused by specific medical disorders.
Low T Lawyer
Schlichter Bogard & Denton is currently investigating claims on behalf of men who believe they experienced adverse events as a result of Low-T therapy. Contact a testosterone therapy lawyer at Schlichter Bogard & Denton to discuss your legal options and review your potential testosterone therapy lawsuit. Your case consultation is free and there is no obligation on your part.
Call toll-free 1-800-873-5297