The Prescribing Information for Testim includes warnings about blood clots in the legs. If these blood clots travel to the lungs, they can cause a life-threatening venous thromboembolism (VTE).
Testim and Venous Thromboembolism (VTE)
Testim, a topical gel used in testosterone replacement therapy, is known to increase the risk of abnormal blood clots in the legs. This condition, deep vein thrombosis (DVT), can lead to a life-threatening complication known as a pulmonary embolism (PE).
The U.S. Food and Drug Administration (FDA) updated the label on Testim in June 2014 to include risk information about DVT and PE. The combination of events is known as a venous thromboembolism (VTE).
According to federal safety regulators:
“There have been postmarket reports of venous blood clots unrelated to polycythemia … 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 Venous Thromboembolism?
Venous thromboembolism (VTE), also known as “venous thrombosis,” begins when blood clots grow inside veins deep inside the body. They usually grow in the calf or thigh, but can also occur in other areas of the body. Veins in the lower part of the body carry blood to the lungs. If there is a blood clot, it can travel to the lungs until it gets stuck in a blood vessel that is too small. This complication is like having a heart attack in your lungs.
Many people do not realize they have DVT until it is too late. The complication often does not produce symptoms in its early stages. When symptoms do appear, many people delay seeking treatment because they do not seem serious. Unfortunately, delayed treatment increases the risk that DVT will lead to life-threatening complications.
Symptoms of a venous thromboembolism:
- Leg swelling (may include ankle or foot)
- Skin discoloration (red, pale, or blue)
- Affected area feels warm
- Pain, discomfort, or tenderness in affected limb
- Sudden shortness of breath or rapid breathing
- Fast heartbeat (tachycardia)
- Chest pain that is sudden, stabbing (especially when breathing deeply)
- Sweating excessively
- Coughing (may contain blood)
- And more