The FDA has required a labeling change to inform consumers of a possible increased risk of heart attack and stroke with use of Low-T products.
On February 3rd, the U.S. Food and Drug Administration published a safety announcement cautioning that prescription testosterone products are approved only for men who have low testosterone levels due to specific medical conditions. These medications have not been approved for treating low testosterone levels in men caused by aging.
The agency is requiring the manufacturers of all approved prescription testosterone products to change their labels to specify the approved uses of the medications as well as information about the possibility of an increased risk of heart attacks and strokes in patients taking testosterone. Additionally, the FDA has required these manufacturers to conduct thorough clinical trials to address whether the use of these Low-T products does, in fact, increase the risk of heart attacks or strokes.
Testosterone products are FDA-approved only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.
Read more about this announcement here.
If you have experienced a heart attack or stroke after taking testosterone replacement medications, such as AndroGel, please contact our attorneys for a free legal consultation.