Testosterone is a naturally occurring male hormone. Prescription testosterone replacement therapy is approved for reduced levels caused by male hypogonadism. Over the past decade or so, testosterone replacement products have been used for “Low-T”. The term “Low-T” is not a diagnosis but a marketing term used to describe low testosterone levels. Some of the symptoms of Low-T are normal signs of aging and not a medical condition. Many men who use testosterone replacement were not tested for low testosterone and may have been unaware of the increased risk of life-threatening side effects such as heart attack, stroke and pulmonary embolism.
Testosterone and Pulmonary Embolism
A pulmonary embolism is the occurrence of a sudden blockage of the arteries that supply blood and oxygen to the lung tissue. If the blood supply is suddenly cut off, the lung tissue cannot survive and will die. Pulmonary embolisms are most commonly caused by blood clots that develop in the legs but may be caused by other non-blood objects in the blood supply such as arterial plaques which have broken into pieces and flow through the arteries to lodge in the lungs.
Testosterone may contribute to the development of pulmonary embolism by changing the body’s ability to process cholesterol and by changing the way the blood cells may interact with each other and begin to clump to create a blood clot. Either of these conditions may result in pulmonary embolism which is often sudden and fatal. It is not easily treated and difficult to predict and even if it doesn’t cause death, it will most often cause permanent lung damage.
Symptoms of pulmonary embolism include:
- Sudden shortness of breath
- Sharp chest pain that worsens with deep breaths or coughs
- Cough that produces bloody or pink mucous
- Heart palpitations or rapid heart rate
Some people with pulmonary embolism do not have symptoms but in others, symptoms may occur rapidly, worsen and quickly become fatal. Symptoms of pulmonary embolism should be treated as a medical emergency.
Testosterone FDA Warnings About Pulmonary Embolism
Testosterone therapy has been shown to have a direct link to thrombosis-pulmonary embolus or pulmonary embolisms. Men who are administered exogenous (replacement) testosterone have been shown to be 5 times more likely to develop respiratory illness including pulmonary
In January of 2014, after the publication of two large studies, the Food and Drug Administration (FDA) announced that they were conducting investigations regarding the increased risk of additional severe adverse events, particularly heart attack. In June of 2014, the FDA issued a separate warning about blood clotting and in 2015, required that a general warning be added to all testosterone products regarding serious side effects including heart attack. This was followed by an additional warning regarding the potential for blood clot development which can cause pulmonary embolism and death.
Side Effects of Testosterone Replacement Treatment
In addition to the risk of clot formation and cholesterol build-up which may result in pulmonary embolism, testosterone may cause other serious side effects which may be life-threatening.
These serious risks include:
- Coronary artery disease
- Heart attack
- Venous thromboembolism
- Deep vein thrombosis
Testosterone also causes a number of side effects which may be less severe but may impair the quality of life.
Thousands of lawsuits have already been filed for serious injury or deaths caused by testosterone replacement, most of which are in men who do not actually have hypogonadism. Many additional lawsuits may be expected and patients or their families may receive monetary compensation for damages such as injury or death as well as punitive damages.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.