All testosterone replacement products, including Axiron (testosterone), have been associated with an increased risk of venous thromboembolism (VTE). This life-threatening medical condition occurs when blood clots get trapped in the lungs, which can cause sudden death.
Axiron and Venous Thromboembolism
Axiron (testosterone) is an underarm liquid product for men with “Low T.” Testosterone is known to thicken the blood and increase the number of red blood cells (a condition known as “polycythemia”).
In June 2014, the U.S. Food and Drug Administration (FDA) warned about reports of VTE from testosterone that were unrelated to polycythemia. The FDA ordered manufacturers of all testosterone products, including Axiron, to add risk information about VTE to the label. The FDA is also investigating the risk of heart attack and stroke from arterial blood clots.
What is Venous Thromboembolism (VTE)?
Venous thromboembolism (VTE) is a severe and often deadly venous blood clot disorder that begins with deep vein thrombosis (DVT) and ends with a pulmonary embolism (VTE). The chain of events usually occurs when a blood clot forms in a deep vein inside the legs, travels in the bloodstream, and gets trapped in the lungs.
At least two out of three people who develop VTE must be hospitalized. Most receive emergency treatment with intravenous (IV) blood-thinning medications or an inferior vena cava (IVC) filter to prevent pulmonary embolism. Even with treatment, about 50% of survivors develop post-thrombotic syndrome, a long-term complication that causes chronic pain, swelling, and ulcers on the legs.
- Leg pain (may only happen when standing)
- Leg swelling, discoloration (redness), warmth to the touch
- Surface veins become more visible
- Shortness of breath or rapid breathing
- Fast heartbeat (tachycardia)
- Chest pain (sudden, stabbing, especially when breathing deeply)
- Sweating excessively
- And more