FDA Adds Blood Clot Warnings on Testosterone ProductsJune 20, 2014 — The U.S. Food and Drug Administration (FDA) is requiring manufacturers of all testosterone replacement products to add general warnings about the risk of venous blood clots.

Testosterone sometimes increases the number of red blood cells in a patient’s bloodstream, a condition known as polycythemia. This can thicken the blood and elevate blood pressure, which may increase the risk of a blood clot.

The label on testosterone gel products, such as Androgel and Testim, already carries warnings about blood clots due to polycythemia. The warnings are not included on non-gel products.

According to the announcement:

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.”

Venous blood clots cause venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE). They do not cause complications like heart attack or stroke, but the FDA continues to investigate studies linking testosterone therapy with these complications.

The FDA issued a Drug Safety Communication about the risk of cardiovascular events in January 2014. They also reiterated that testosterone therapy is only approved for the treatment of men with low testosterone due to an associated medical condition, such as genetic problems, chemotherapy, or failure of the testicles to produce testosterone.

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