Testosterone is a male hormone that is naturally occurring in the human body. It is available as a medication to treat hypogonadism which causes a deficiency of the hormone in men but in the recent past, testosterone has been prescribed to treat “Low-T”.
Like many hormones, testosterone levels begin to decline naturally as men age. This is a normal process of aging and not a medical condition. In addition, some natural symptoms of aging are being interpreted by men as “Low-T” due to advertising.
“Low-T” is a marketing term and not an actual medical diagnosis. It is intended to refer to low testosterone levels but a majority of men who are using testosterone replacement have never had laboratory testing done to check their hormone levels. Some estimates show that up to half of the men using testosterone replacement do not actually have low testosterone levels and the medication is not approved to treat age related decline.
Approximately 3 percent of men over the age of 40 may be using testosterone replacement therapy. The testosterone market is currently estimated at about $2 billion annually and is expected to more than double by 2017. Testosterone therapy has a number of side effects, some of which are life-threatening and may result in death such as the increase risk of stroke, pulmonary embolism, coronary artery disease, and heart attack.
Hundreds of lawsuits have already been filed against the manufacturers of testosterone replacement products due to serious injury or death including nearly 200 cases in one federal court in Illinois. Additional lawsuits have also been filed at the state and local levels and also in Canada.
Side Effects of Testosterone Replacement Treatment
All medications cause side effects and most are not life-threatening but some adverse events caused by testosterone are severe and may result in death. Other side effects caused by testosterone may be mild to moderate but they may interfere with a patient’s quality of life.
Mild to moderate side effects which are usually not life-threatening of testosterone include:
- Oily skin
- Heavier facial and body hair
- Increased sex drive
- Weight gain
- Prostate enlargement
- Testicular atrophy
- Oligospermia (slow sperm)
- Gynecomastia (male breast development)
- Increased risk of prostate cancer
- Increased risk of liver damage
Testosterone can also cause some side effects which can contribute to more dangerous severe adverse events such as:
- Apnea (sleep apnea and other difficulty breathing)
- Increases in blood laboratory test levels (hemoglobin ad hematocrit)
- Cholesterol metabolism disturbance
- Blood clot development
These more serious side effects can increase the chance of developing a life-threatening condition such as pulmonary embolism, stroke, coronary artery disease, or heart attack.
About Coronary Artery Disease and Heart Attack
Coronary artery disease is caused by a narrowing of the arteries that supply blood and oxygen to the heart tissue. This is a result of the development of cholesterol based deposits known as plaques along the inside of the arteries, also called atherosclerosis or arteriosclerosis.
Over time, blood flow will be constricted leading to a weakening of the heart muscle. The blood vessels may eventually become completely blocked and require a balloon dilation procedure known as angioplasty. If angioplasty is not possible, a heart bypass may be required to replace the arterial blood flow.
Myocardial infarction (MI) or heart attack is caused by a sudden blockage of the blood flow to the heart muscle. If the cardiac muscle does not have oxygen supply, the tissue will die. In some cases, CAD may lead to heart attack but in other cases, heart attack may be caused by a blood clot which has developed elsewhere in the body.
Symptoms of heart attack include:
- Sudden pain in the chest, back, arm, shoulder or jaw on one or both sides
- Sudden pressure sensation of the chest
- Sudden anxiety
- Shortness of breath
- Lightheadedness or dizziness
- Sweating with cold, clammy skin
Symptoms of heart attack should be treated as a medical emergency.
Testosterone, Coronary Artery Disease and Heart Attack
Testosterone use can increase the chances of developing CAD which can lead to heart attack because of changes in the body’s metabolism of cholesterol. Testosterone use has also been shown to increase the risk of heart attack due to blood clot development.
Blood clots are formed in the body when a tissue is injured or when blood cells are travelling too slowly or are too close together. Testosterone increases blood clot formation in two ways.
Because one of the side effects of testosterone use is increased hemoglobin and hematocrit levels, the blood can be slightly thicker than normal. Testosterone also increases the production of a body chemical known as thromboxane which increases the blood pressure through vasoconstriction. When the blood is thicker and under greater pressure, blood cells will begin to clump together and develop a clot.
The changes in cholesterol metabolism by testosterone may also increase the risk of clot formation due to the narrowing of arteries and veins. Narrowed sections of the blood vessels cause the blood cells to “bump” into each other near the plaque deposit and develop a clot. Clots can be formed anywhere in the body but most commonly develop as deep vein thrombosis (DVT) in the legs. Once formed, they break free and travel to the brain, heart, or lungs. Clots that travel to the heart may cause a heart attack.
A link has been shown between the development of DVT and testosterone use. The FDA began an investigation regarding testosterone and an increased risk of heart attack in January of 2014 and followed with a warning of the risk of clot formation. The FDA now requires that warning to be included on all testosterone products but many men had already had severe adverse events from the medication.
Many men have used testosterone replacement therapy to aid with the naturally occurring symptoms of aging. Though they may have reportedly used the medication for “Low-T”, they may not have been tested for low testosterone levels at all and do not actually have lower than normal testosterone levels. In addition, they may not have been made aware of the life-threatening risks of testosterone use.
Men who have used one of the multiple testosterone replacement products on the market have experienced serious side effects including pulmonary embolism, stroke, and heart attack. Some deaths have also been attributed to testosterone use.
Hundreds of lawsuits have been filed in the US and in Canada. Nearly 200 federal lawsuits have been consolidated into multi-district litigation (MDL) in the US District Court for the Northern District of Illinois as supervised by Judge Matthew F. Kennelly but lawsuits have also been filed in state and local courts as well.
Attorneys for injured patients have claimed that the manufacturers:
- Aggressively promoted testosterone for “Low-T” and encouraged its use without necessary testosterone blood level testing
- Failed to warn both the medical community and the public about the serious risks of testosterone use
Plaintiffs may be eligible for monetary awards for actual damages due to serious injury or death and for punitive damages. Many additional testosterone therapy lawsuits are expected.