Testosterone replacement therapy is also known as androgen replacement therapy. It is approved only for use in men who have low testosterone levels due to either male primary hypogonadism caused by a malfunction of the testes or male secondary hypogonadism caused by malfunction of the pituitary gland.
When a man has hypogonadism, the body fails to make enough androgens like testosterone which is responsible for the male secondary sex characteristics such as deepened voice, penis and testes development, facial hair and male musculature.
Testosterone therapy has become popular for men who believe they have “Low-T”, however recent analysis suggests that over half of the men who are using testosterone replacement products actually have low testosterone levels. Testosterone levels naturally begin to decline as a man ages, but this is a natural part of aging and not a medical problem. Some data analysis suggests that a majority of men who are using testosterone for symptoms that are similar to age related decline, have never been tested for low testosterone levels.
As testosterone replacement therapy has not been approved for age-related decline, few studies have examined the effectiveness or safety. In addition, studies analyzing use patterns indicate that testosterone therapy can increase the chance of a serious adverse event (SAE) such as heart attack, stroke or death by two-fold for men over 65 and up to three-fold for those under 65 with a cardiac medical history.
Testosterone therapy may be used by nearly 3 percent of men over the age of 45 in the US and sales are estimated to reach $5 billion per year by 2017. At least 200 lawsuits have been filed regarding serious injury or death caused by testosterone therapy and many more are expected.
Side Effects of Testosterone Replacement Treatment
Like all medications, testosterone therapy has a number of side effects. Most of the side effects are not severe but may interfere with a patient’s quality of life. Other side effects are serious adverse events and may be life-threatening.
Mild Testosterone Side Effects
Most of the side effects caused by testosterone occur because it is a male hormone. Common side effects which are generally not considered dangerous can include:
- Oily skin
- Increased body hair and facial hair growth
- Aggressive tendencies
- Weight gain
- Increased sex drive
- Hot flushes
Moderate Testosterone Side Effects
Some side effects may be more damaging to the quality of life such as:
- Priapism (prolonged erection)
- Prostate enlargement
- Difficulty Urinating
- Elevated PSA levels
- Testicular atrophy (shrinkage)
- Oligospermia (slow sperm)
Testosterone may also cause:
Liver Damage – Testosterone is metabolized by the liver and may increase the risk of liver cancer, hepatic encephalopathy, and liver failure.
Prostate Cancer – Testosterone may impair prostate functioning and increase PSA levels, leading to the development of prostate cancer
Danger to women and children – Testosterone is a male hormone and may cause male characteristics to develop in women or children who come into contact with the medication. It should not be used by women or children except in rare cases.
Serious Testosterone Side Effects
Life Threatening Side Effects
Some of the side effects that contribute to those serious medical conditions include:
- Hypertension or high blood pressure
- Difficulty breathing
- Sleep Apnea
- Weight gain
- 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. Blockage of arteries that supply the heart with blood and oxygen. Blockages are usually developed slowly over a period of time due to impaired cholesterol metabolism. Diabetes, hypertension, obesity, and sleep apnea are thought to increase the risk of development of CAD. May cause heart failure, heart attack, or death.
Myocardial infarction –MI. Heart attack or death of cardiac tissue caused by blockage of blood flow to heart muscle. Can be caused by an embolism such as a blood clot or by blockage of the arteries with cholesterol or plaque development. May result in death.
Pulmonary embolism – PE. Blockage or death of lung tissue caused by a foreign body such as a blood clot or a portion of an arterial plaque that has broken off and traveled to the lungs. May result in death.
Cerebrovascular Accident – CVA. Stroke caused by blockage of arteries supplying brain with blood and oxygen. Blockages are usually caused by blood clots or a portion of an arterial plaque that has broken off and traveled to the brain. May result in death.
In January 2014, the FDA announced investigation of serious adverse events caused by testosterone replacement therapy. This was following the publication of results from two studies showing a two or three times increase in heart attack and stroke risk for men over the age of 65 and those under the age of 65 with a history of cardiac events. Up to half of all men using testosterone therapy may never have been tested for low testosterone levels. Many men are using testosterone for age-related symptoms such as lack of energy, loss of libido and poor bone density.
Well over 200 lawsuits have been filed, with most of those being federal lawsuits. All of the federal cases have been consolidated into multidistrict litigation (MDL) in the US District Court for the Northern District of Illinois as supervised by Judge Matthew F. Kennelly. These lawsuits have been filed against a number of testosterone replacement products. In addition to the federal cases, lawsuits also are being filed at the state level and also in Canada due to injury and death caused by testosterone replacement.
Attorneys for the victims have claimed that manufacturers have aggressively promoted the therapy for unapproved uses and encouraged the use of the medication without appropriate testing. They also claim the companies have failed to adequately warn against and minimized the serious threats of testosterone use such as heart attack, stroke, pulmonary embolism, and death.
Many more lawsuits are expected and victims may be eligible for medical costs, punitive damages and other damages due to injury or death associated with testosterone use. Testosterone lawsuits may eventually reach into the thousands.