Venous thromboembolism (VTE) has been added to the list of side effects associated with Fortesta (testosterone gel) and other testosterone replacement products. This life-threatening event involves blood clots in the legs that travel to the lungs.
Fortesta and Venous Thromboembolism (VTE)
Fortesta (2% testosterone) is associated with polycythemia, a condition in which bones produce extra red blood cells. This can potentially increase the risk of developing a blood clot in the leg. If the blood clot breaks loose, it could travel to the lungs and cause a venous thromboembolism (VTE).
The U.S. Food and Drug Administration (FDA) required the manufacturers of Fortesta to include risk information about venous blood clots, including VTE, some of which were unrelated to polycythemia. They also published a Safety Alert for all testosterone replacement products, but cautioned that venous clots do not cause heart attack or stroke.
What is Venous Thromboembolism (VTE)?
Venous thromboembolism (VTE) refers to a chain of events that begins with deep vein thrombosis (DVT), in which blood clots form in veins deep inside the body. VTE culminates when a blood clot travels through the bloodstream, gets trapped in the lungs, and causes a pulmonary embolism (PE).
The Centers for Disease Control (CDC) has provided a resource, Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), describing statistics on VTE in the United States every year:
- VTE affects 300,000-600,000 Americans every year
- Within one month, VTE is deadly in about 10-30% of cases
- The first symptom in 25% of pulmonary embolisms is sudden death
- Post-thrombotic syndrome is a long-term complication that occurs in half of people with DVT, causing chronic pain, swelling, discoloration, and ulcers
Symptoms of VTE
- Leg pain or discomfort (may only occur when standing)
- Leg swelling (edema)
- Red discoloration of the skin
- Chest pain (worsens when breathing deeply)
- Shortness of breath
- Fast heartbeat
- Excessive sweating
- Coughing (may produce bloody sputum)
- Faintness or light-headedness
- And more