New Low T Warning Required By Food and Drug Administration

FDA Requires New Warning Label for Testosterone Drugs

The U.S. Food and Drug Administration has announced that testosterone products must now carry a warning label about the general risk of blood clots in the veins.  Blood clots in the veins may include conditions such as pulmonary embolism or deep vein thrombosis.  These are serious health conditions that can be fatal if a blood clot travels into the lungs.  The labeling change for low testosterone drugs is not the first time that the treatments have been in the spotlight for potential serious health conditions that could accompany their use.

There has been much discussion on the safety and potential side effects regarding testosterone prescribed to treat men with low testosterone or “low-t”. Studies have shown a link between serious adverse health events such as heart attacks, strokes and even death in some patients that have used testosterone replacement therapies.  A warning about the risk of blood clots relating to a condition known as polycythemia (an abnormal rise in the number of red blood cells) has already been in place for patients taking low t treatments.  This new warning requirement is not related to the previous warning for polycythemia or the FDA’s continuing investigation into the heart attacks, strokes and deaths that have been reported in some patients that took low t drugs.

The number of prescriptions written for low testosterone treatments has dramatically increased in the past several years and more and more men have taken these treatments to combat conditions such as low sex drive, weight gain and loss of energy.  Anyone considering low testosterone replacement therapies or already taking low t drugs should have a thorough conversation with their doctor about these potential risks.

Patients that have been harmed by taking low testosterone drugs may be entitled to financial compensation.  If you or someone that you know has been harmed by taking low testosterone drugs, please contact the Law Offices of Michael A. DeMayo, L.L.P. for a free case evaluation.  The Law Offices of Michael A. DeMayo can be reached toll free at (877) 333-1000 or via email at