AndroGel, one of the most popular testosterone gel products, can increase the risk of venous thromboembolism (VTE). This life-threatening medical condition occurs when blood clots form (usually in the legs), travel in the bloodstream, and clog arteries in the lungs.
AndroGel and Venous Thromboembolism (VTE)
In July 2014, the U.S. Food and Drug Administration (FDA) ordered AbbVie, the manufacturer of AndroGel, to add Safety Warnings about Venous Thromboembolism (VTE) to the label.
The FDA has received reports linking testosterone replacement therapy with VTE, including cases that were not related to polycythemia. Polycythemia a side effect in which testosterone boosts the number of red blood cells and elevates blood pressure.
What is Venous Thromboembolism (VTE)?
AndroGel is known to increase the risk of blood clots in the legs. This complication is also known as deep vein thrombosis. DVT is not usually life-threatening on its own. However, when blood clots in the legs break loose (called an “embolism”), they can travel in the bloodstream until they get trapped in smaller blood vessels in the lungs. This is called a pulmonary embolism (PE), and about 30% of untreated cases are deadly. The combination of a blood clot, DVT, and PE is known as a venous thromboembolism (VTE).
Symptoms of Deep Vein Thrombosis (DVT):
- Leg pain, tenderness
- Swelling (edema)
- Warm skin near the blood clot
- Surface veins become more visible
- Skin discoloration (redness)
Symptoms of Pulmonary Embolism (PE):
- Rapid breathing and shortness of breath
- Chest pain (stabbing or sharp pain with deep breaths)
- Coughing up blood
- Rapid heartbeat (tachycardia)
- And more
A doctor will administer blood-thinning medications, which may include heparin or warfarin, to prevent blood clots from forming or growing larger. In the hospital, patients may also receive “clot-busting” (thrombolytic) drugs that help dissolve existing clots.
In very serious cases, doctors may use a technique called catheter-directed thrombolysis to inject clot-dissolving medications directly into the blood clot. For patients who cannot use blood-thinners, doctors may have to implant a medical device called an inferior vena cava (IVC) filter to catch blood clots before they cause a PE.