On 6/19/2014, the FDA issued a drug safety statement affecting all FDA-approved testosterone products currently on the market.
According to the statement:
“[FDA] 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, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).”
“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.”
This new warning is in addition and independent of the ongoing FDA investigation of the risks of stroke, heart attack, and death in patients who use testosterone replacement products.