Treatments for low testosterone may pose serious health risks not included on medication warnings and labeling. Recent studies and mounting lawsuits point to an association between low-testosterone treatments and an increased risk of heart attack, blood clot and stroke.
Following a January, 2014 FDA safety investigation notice, several drug manufacturers of Low-T treatments are facing lawsuits from patients who claim the drugs caused heart attack, stroke, blood clots and other serious problems. Most of these lawsuits allege the drug manufacturers failed to warn men of the potential risk of cardiac events.
Evidence has surfaced that treatments for low testosterone, including AndroGel, may double the risk of heart attack for certain men. A study published in January, 2014, titled "Testosterone Therapy and Myocardial Infarction," showed a link between testosterone therapy and cardiovascular disease. Researchers found that in men over the age of 65 and men under 65 with preexisting heart disease, the risk of heart attack doubles as a result of testosterone therapy.
In another study from November, 2013, researchers also concluded that testosterone therapy increases cardiovascular risk. The study was published in the Journal of the American Medical Association. The researchers concluded the association between the drugs and heart attacks required further investigation.
Some of the drug brands currently facing litigation as a result of heart attack and stroke suffered by low testosterone patients include AndroGel and Testim. As a result of the two studies, the FDA is currently investigating the risk of heart attack, stroke and death from low-T treatments.