The Prescribing Information for Fortesta (testosterone gel) has been updated to include venous thromboembolism (VTE), a life-threatening venous blood clot disorder.
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Fortesta and Venous Thromboembolism (VTE)
Fortesta is a gel that contains 2% testosterone, a powerful male hormone. The Prescribing Information warns that Fortesta is associated with a medical condition called polycythemia, in which bones produce more red blood cells. This condition is associated with an increased risk of venous thromboembolism (VTE), in which blood clots from the legs travel to the lungs.
In June 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Communication to warn that Fortesta has been linked to cases of VTE that were unrelated to polycythemia. The FDA required drug-makers to update the side effects to include venous blood clots. However, they cautioned that venous blood clots do not cause heart attack or stroke.
What is Venous Thromboembolism (VTE)?
Testosterone replacement therapy can thicken the blood and increase the risk of blood clots in the legs, a condition known as deep vein thrombosis (DVT). The most serious complication of DVT occurs when pieces of the blood clot break loose, travel in the bloodstream, and get stuck in the lungs. This complication is known as pulmonary embolism (PE). The combination of a DVT/PE is known as a venous thromboembolism (VTE) or “venous thrombosis.”
The Centers for Disease Control (CDC) reports the following statistics on VTE in the United States:
- 300,000 to 600,000 people are affected by VTE in the United States every year
- 10-30% of them die within one month of diagnosis
- VTE is responsible for about 60,000 to 100,000 deaths per year
- Sudden death occurs in about 25% of people who have a pulmonary embolism
- 50% of people who have DVT develop long-term complications (post-thrombotic syndrome), causing swelling, pain, discoloration, and ulcers in the legs.
Symptoms of VTE
- Pain or discomfort in the leg (calf or thigh)
- Leg swelling, red discoloration, and warm skin
- Surface veins become more visible
- Shortness of breath or rapid breathing
- Chest pain that worsens with deep breaths
- Rapid breathing
- Rapid heartbeat
- Coughing (may contain bloody sputum)
- Feeling unwell or anxious
- And more
- Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) — Centers for Disease Control (CDC)
- Treatment of Venous Thromboembolism — Circulation (2004)
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