FDA adding general warning to testosterone products potential for venous blood clots

The US Food and Drug Administration is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.

Blood clots in the veins, ie, venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment.

Because there have been post-market reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.