The Food and Drug Administration today took the bold step of requiring the makers of testosterone replacement therapies to place new labels on their products warning of increased risks of cardiovascular problems such as heart attacks and strokes.
Additionally, the FDA advised doctors against the overuse of so-called Low T drugs in men, stressing that they are only approved to treat low testosterone levels caused by disease or injury, and not normal signs of aging.
"The benefits and safety of this use have not been established," the FDA said in a statement issued today.
The move is a stinging rebuke for the drug makers who are facing hundreds of lawsuits from men who have suffered serious injuries while on or shortly after taking drugs such as AndroGel, AndroDerm, Testim and Fortesta.
The FDA's review was prompted last year by studies that showed an increased risks of serious injuries in older men who were on testosterone replacement therapies.
Ross Feller Casey is representing more than 230 men who were suffered severe injuries as a result of Low T drugs. The firm is the recognized leader in such cases.
If you or a loved one suffered a stroke, blood clot in the lungs, blood clot in the deep veins, heart attack, or death while on testosterone replacement therapies, you may consider filing a testosterone lawsuit. You should contact one of Ross Feller Casey's experienced Low T lawyers now for a free consultation.
To learn more, go to www.rossfellercasey.com/practice-areas/lowtlawsuit/