Testosterone is a naturally occurring male hormone. Prescription testosterone replacement is approved for male hypogonadism for cases in which there is not enough testosterone being produced. Over the past decade or so, more testosterone replacement products have become available and are currently being used for “Low-T”. The term “Low-T” is a new marketing term used to describe low testosterone levels.
Testosterone levels do naturally decline as men age but some of the symptoms of “Low-T” are actually normal symptoms of aging. Up to 3 percent of men over the age of 40 may be using testosterone therapy and over half of these men have never been tested for low testosterone levels. In addition, testosterone replacement therapy has not been approved by the Food and Drug Administration for age-related testosterone deficiency.
The current testosterone replacement market is estimated at $2 billion annually and may reach $5 billion by 2017. Testosterone replacement may cause side effects, many of which are mild to moderate but it may also cause severe and life-threatening adverse events such as heart attack, stroke and pulmonary embolism.
At least 200 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.
Side Effects of Testosterone Replacement Treatment
Testosterone, like most medications has a number of side effects. As testosterone is a male hormone, the side effects are hormonal in nature. Some of these side effects are mild or moderate and may impair the quality of life such as:
- Acne and oily skin
- Increased body and facial hair
- Aggressiveness and increased sex drive
- Thickening of the bones
- Headache and hot flushes
- Prostate enlargement
- Testes atrophy
- Slow Sperm
Testosterone may also cause liver damage and prostate cancer and can be dangerous to women and children who come into contact with the medication. It may also cause more serious side effects which increase the risk of death such as:
- Difficulty breathing
- Elevated hemoglobin and hematocrit levels
- Impaired cholesterol metabolism
- Blood clots
These side effects may result in the life-threatening conditions of coronary artery disease (CAD), myocardial infarction (MI) or heart attack, cerebrovascular accident (CVA) or stroke and pulmonary embolism (PE) all of which may cause death.
About 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 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.
Pulmonary embolism 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 others may rapidly become worse and even die. Symptoms of pulmonary embolism should be treated as a medical emergency.
Testosterone and Pulmonary Embolism
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 clot.
Testosterone therapy has been shown to have a direct link to thrombosis-pulmonary embolus or pulmonary embolisms. Subjects who are administered exogenous (replacement) testosterone have been shown to be 5 times more likely to develop respiratory illness including pulmonary embolism.
In 2009, the FDA required an additional warning to testosterone products regarding the threat of adverse events in women and children. In January of 2014, the FDA announced investigations regarding the increased risk of additional severe adverse events, particularly heart attack. In June of 2014, the FDA added a general warning to all testosterone products regarding the potential for blood clot development which can cause pulmonary embolism.
Unfortunately, many men are using testosterone replacement therapy for the treatment of naturally occurring symptoms of aging and may not have been made aware of the threat of severe adverse events such as heart attack, pulmonary embolism, and death.
Some men who have used testosterone therapy for “Low-T” or low testosterone levels have experienced life-threatening side effects including heart attack, stroke, and pulmonary embolism. Testosterone has also been attributed to some deaths and many of the men taking testosterone have never actually been tested for low levels of the hormone.
Hundreds of lawsuits have already been filed at the federal, state, and local levels against the manufacturers of several types of testosterone replacement products such as AndroGel and Testim. Nearly 200 of the federal lawsuits have been consolidated into multidistrict litigation (MDL) in the US District Court for the Northern District of Illinois under supervision by Judge Matthew F. Kennelly
Plaintiffs have claimed that the manufactures have aggressively promoted testosterone, encouraging the use of the medication without proper testing. Plaintiffs also claim that patients and the medical community were not adequately warned about the serious risks of testosterone use including heart attack, stroke, pulmonary embolism, and death
Many additional lawsuits are expected to be filed and patients or their families may receive monetary compensation for damages such as injury or death as well as punitive damages. Learn more about testosterone lawsuits here.