The use of testosterone is associated with an increased risk of deep vein thrombosis (DVT) or blood clots in the legs. If these blood clots travel in the bloodstream, they can get trapped in the lungs and cause a deadly pulmonary embolism.
Testosterone and Deep Vein Thrombosis (DVT)
Testosterone replacement products increase the risk of deep vein thrombosis (DVT), or blood clots in the legs. The problem is that testosterone sometimes increases the number of red blood cells in the body (polycythemia), thickens the blood, elevates blood pressure, and imbalances levels of estrogen — all risk-factors for blood clots.
DVT Warnings Added on All Testosterone Products
In June 2014, the U.S. Food and Drug Administration (FDA) announced that the manufacturers of all testosterone replacement products must add warnings about the risk of venous blood clots, including DVT.
Before this Safety Communication, only testosterone gels (AndroGel, Fortesta, etc.) carried warnings about blood clots in the legs. The FDA concluded that DVT is a potential side effect of all testosterone products, and it is not necessarily a complication of polycythemia.
According to the FDA:
“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. Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.”
What is Deep Vein Thrombosis(DVT)?
Deep Vein Thrombosis (DVT) is a serious medical condition that occurs when blood clots grow in veins deep inside the body. In most cases, the blood clots grow in veins in the lower leg (calf) or thigh. DVT can also occur in the pelvis, arms, or other areas of the body.
- Skin discoloration (redness)
- Leg pain or discomfort
- Swelling (edema)
- Veins become more visible
- Skin is warm to the touch
When a blood clot forms in the lower part of the body, it can potentially travel in the bloodstream (becoming an “embolism”) and get trapped in the lungs. This complication is called a pulmonary embolism (PE). If the obstruction is large enough, it can cause severe hypoxia (low oxygen in the bloodstream) and death.