June 20, 2014 — The manufacturers of testosterone replacement products must add warnings about the risk of venous blood clot complications, including pulmonary embolism (PE), deep vein thrombosis (DVT), and venous thromboembolism (VTE).
The label on testosterone gel products, such as Androgel and Fortesta, already carries warnings about the risk of blood clots from polycythemia, a side effect in which testosterone boosts the number of red blood cells and thickens the blood.
However, the FDA says all testosterone products — not just gels — must carry warnings about blood clots that are unrelated to polycythemia.
According to the Safety Communication:
“Because there have been postmarket 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.”
The FDA cautioned that these new warnings are unrelated to the ongoing investigation of recent studies linking testosterone therapy and cardiovascular events. Venous blood clots do not cause heart attack or stroke.
The FDA also reiterated that testosterone therapy is only approved for men with low testosterone due to a medical condition, such as chemotherapy side effects, testicles that do not produce hormones, or genetic diseases.
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