Testosterone replacement therapy is approved to treat low testosterone levels in cases where the body is not making enough of the hormone. It is a naturally occurring hormone that is responsible for male sex characteristics such as facial and body hair, heavy musculature and male sex organ development.
Over the past several years, testosterone replacement therapy has been prescribed for “Low-T”, which is a term coined by the pharmaceutical industry and used in reference to low testosterone levels. Testosterone levels naturally decline in men who are aging but some of the symptoms of aging and low testosterone levels are similar. In addition, many men have used the medication but have never been tested for low testosterone levels.
Currently, as many as 3 percent of men ages 40 and above may be using testosterone therapy at a total cost of $2 billion annually even though the medication has not been approved to treat age related testosterone decline.
Testosterone therapy has caused severe side effects such as heart attack, pulmonary embolism and cerebrovascular accident (CVA) or stroke in some men and can result in death. At least 200 lawsuits have already been filed against the manufacturers of testosterone at the federal, local and state levels in the US and also in Canada because of serious injury.
Side Effects of Testosterone Replacement Treatment
All medications carry some side effects. Most of the side effects caused by testosterone are hormonal type side effects and are mild to moderate, however some of the side effects of testosterone can be life threatening.
Less severe side effects include:
- Increased facial and body hair growth
- Oily skin and acne
- Aggressive behavior
- Increased libido (sex drive)
- Skeletal thickening and muscle growth
- Hypertension, hot flushes and headaches
- Prostate growth and atrophy of the testicles
- Slow sperm
- Gynecomastia (male breast growth)
Testosterone can also result in liver damage and prostate cancer in men and should not be used by children or women, except under rare circumstances. Testosterone can also cause severe side effects which may be life threatening and include:
- Difficulty breathing (apnea)
- Increased hemoglobin and hematocrit levels
- Changes in cholesterol metabolism
- Blood clot formation
These side effects may increase the chance of heart attack, coronary artery disease, pulmonary embolism and stroke or cerebrovascular accident (CVA). Any of these serious adverse events may also result in death.
About Cerebrovascular Accident or Stroke
A stroke, also known as a cerebrovascular accident or CVA is the occurrence of a sudden blockage of the arteries that supply blood and oxygen to the brain. When the supply of blood and oxygen to the brain is blocked, the brain tissue cannot survive. CVAs are most often caused by blood clots that have developed elsewhere in the body but may also be caused by arterial or venous plaques from atherosclerosis that have broken off, producing a piece that may lodge in an artery.
Strokes occur suddenly and are not always treatable. In some cases, a CVA will cause permanent damage to the brain and may even result in death. Damage to the brain can result in physical disability which is permanent.
Symptoms of stroke include:
- Sudden numbness or weakness of face or limbs (arm or leg), often on only one side of the body
- Sudden confusion or difficulty speaking
- Sudden dizziness, loss of balance or coordination
- Sudden headache
Symptoms of stroke should be treated as a medical emergency as any treatment must be done immediately but will not always work.
Testosterone, Blood Clots and Cerebrovascular Accident
Taking testosterone may increase the risk of CVA or stroke because of an increased chance of clotting. In addition, changes in the body’s cholesterol metabolism may increase the risk of atherosclerosis.
Testosterone increases the chance of clot formation in two ways. A common side effect of testosterone therapy is polycythemia which increases the body’s supply of hemoglobin and hematocrit, affecting the blood cells. This can increase the blood pressure and thicken the blood slightly.
Thicker and slower moving blood causes the blood cells to “bump” into each other more often and clump together as a blood clot. Testosterone is also known to increase production of thromboxane, a blood vessel constrictor which also may increase the risk of clot formation.
Testosterone also changes the body’s metabolism of cholesterol and may lead to the formation of plaques in the arteries and veins. As the blood is restricted in moving past the plaques, it can create blood clots and in some cases, the plaque may become loose. In either case, a solid or semi-solid particle can travel to the brain and cause a stroke.
In most cases, clots are formed in the legs in a condition known as deep-vein thrombosis. These clots can travel to the brain, heart or lungs and can be fatal.
A 2013 study published in Clinical and Applied Thrombosis/Hemostasis showed a link between DVT hospitalization and testosterone use. The FDA announced an investigation in January of 2014 regarding severe adverse events caused by testosterone, particularly heart attack but in June of 2014 the FDA began requiring a warning regarding the risk of clot formation on all testosterone products.
Many of the men who are using testosterone replacement products have never been tested for low testosterone levels. A large percentage of testosterone products may be in use for naturally occurring symptoms of aging, by men who have not been made aware of the serious risks.
Many men who have used testosterone replacement therapy have experience serious adverse events such as heart attack, pulmonary embolism and stroke, some of which resulted in death. Up to half of all men taking testosterone have never been tested for “Low-T”.
Over 200 lawsuits have already been filed at the federal, state, and local levels in the US and also in Canada. Manufacturers of testosterone products such as Testim and AndroGel have been accused of aggressively promoting testosterone for “Low-T” and for encouraging its use without appropriate testosterone level blood tests. The companies have also been accused of minimizing or failing to warn the medical community and the public regarding the potential for severe side effects.
Many of the testosterone lawsuits have been consolidated into multi-district litigation (MDL) in the US District Court for the Northern District of Illinois under supervision by Judge Matthew F. Kennelly but thousands of lawsuits may still be filed.