As many as 2.9 percent of American men, over the age of 40, are undergoing testosterone replacement or treatment therapy. This is a four-fold increase in numbers since just 2000. It is estimated that sales of the multiple available testosterone replacement products could reach as high as $5 billion by the year 2017. Currently American men spend more than $2 billion on testosterone replacement each year.
An ever-increasing number of men are having their testosterone or “T” levels tested as they have been led to believe that falling testosterone levels can be easily corrected with Testosterone Replacement Therapy for their “Low T” problem. In actuality, the problem may be one of simple aging and should not be “fixed” by hormone replacement.
Testosterone replacement therapy, also known as androgen replacement therapy has traditionally been used to treat male hypogonadism. With this condition, the body fails to make enough male hormones or androgens. Testosterone is an androgen and is responsible for most of the male secondary sex characteristics like facial hair, low voice and sexual organ development. In male hypogonadism, the testicles do not make enough androgens such as testosterone, either due to a pituitary problem or a testicular problem.
Testosterone replacement is effective and necessary for males who have a testicular or pituitary malfunction and while it is true that men lose testosterone production as they age, it has only began to be considered a medical problem in the last decade or so. Experts warn that the long-term effects of testosterone use have not been adequately studied, particularly when given for a disease that does not actually exist.
What is Testosterone Replacement Therapy
Testosterone is hormone found in men, responsible for the proper development of male sexual characteristics such as, muscle bulk, bone growth, facial hair, and sexual function.
Testosterone replacement medications are approved to treat primary hypogonadism (congenital or acquired) which is caused by genetic defects, toxicity or conditions resulting in testicular failure such as chemotherapy, trauma, or injury. It is also approved to treat secondary hypogonadism (congenital or acquired) which is caused by a malfunction of the pituitary gland from due to genetic defects or due to tumors, trauma, or radiation.
Many men who are using testosterone replacement therapy today are actually using it to combat natural effects of aging which is an “off-label” use. None of the products approved as prescription testosterone replacement are approved for use in men who lack a diagnosed medical condition that is related to the low testosterone level. Physicians are able to use medications for “off-label” use, but drug companies are prohibited from marketing medication for unapproved reasons.
Despite the approved indications of actual hypogonadism and the lack of approval for age-related decline in testosterone levels, most men who are using testosterone replacement therapy to help with the natural decline of
testosterone due to aging. Some other men are using it as a performance enhancer for athletics, which is not only an unapproved indication but also prohibited in competitive sports.
Testosterone therapy can be administered as a gel, a patch or injection. A few products that treat low or inadequate testosterone levels are:
- AndroGel (AbbVie)
- Androderm (Actavis)
- Axiron (Eli Lilly)
- Bio T Gel
- Testim (Auxilium)
Side Effects of Testosterone Therapy Treatment
Like most other medications, testosterone replacement has a number of side effects. Testosterone replacement has been linked to cardiac and vascular problems including heart attacks and stroke.
Mild Testosterone Side Effects
Testosterone has a number of side effects which occur because it is a male hormone.
Common side effects that are not dangerous to most and may be considered beneficial in some cases may include:
- Aggressive behavior
- Oily skin
- Increased body hair growth
- Increased sex drive
- Weight gain
- Hot flushes
Prostate and Testicular effects
Testosterone replacement has been shown to increase the risk of prostate disorder including:
- Prostate enlargement
- Difficulty urinating
- Elevated PSA levels
- Prostate cancer
Some men also see testicular atrophy (shrinking testicles), particularly with long term use, oligospermia (slow sperm) and priapism (extremely prolonged erection – can cause penile damage).
Testosterone may increase the risk of heart attack and stroke.
Testosterone increases the risk of conditions that may contribute to cardiac and vascular problems such as:
- Difficulty breathing
- Sleep Apnea
- Elevated hemoglobin and hematocrit
- Impaired cholesterol metabolism
- Blood clots
Studies have shown that men over the age of 65 may have double the normal heart attack risk with testosterone therapy and this was seen within short term use (under 90 days). Among younger men, those with a history of heart disease had a two to three-fold increase for the risk of heart attack within the first 90 days of treatment. In younger men without previous cardiac history, no increased risk was shown.
Men who have other conditions such as hypertension, diabetes or poor cholesterol profiles may also be at an increased risk of both heart attack and stroke.
Testosterone is metabolized in the liver and use of testosterone and other hormones has been shown to increase liver enzyme levels. Those who use testosterone for a long period of time may be at an increased risk of liver cancer, hepatic encephalopathy or liver failure. It is suspected that some well-known athletes may have developed liver cancer after years of steroid (testosterone) use.
Dangers to Women and Children
As testosterone is responsible for the male secondary sex characteristics, it should not be taken or used except under rare circumstances. Women and children who come into skin contact with testosterone gel or other forms of testosterone may absorb some of the medication which could result in adverse events. Testosterone can cause the development of male characteristics such as body hair, deepened voice, reproductive anomalies in women and children and may cause the long bones (arms and legs) to stop growing prematurely in children.
In January of 2014, the U.S. Food and Drug Administration announced its investigation of AndroGel and other testosterone replacement treatments used for men. The investigation was prompted by the results of two studies. One of the studies showed a two-fold increase in heart attacks in those on testosterone who were over the age of 65. The second study showed a connection between testosterone and increased risk of both stroke and heart attack.
Previous similar investigations have led the FDA to issue warnings regarding suspect medication.
A number of lawsuits have been filed against Abbott Laboratories and AbbVie, the manufacturers of AndroGel due to heart attacks, strokes and blood clots that occurred after the use of AndroGel. The first five lawsuits were filed just four days after the FDA safety announcement was released. Additional testosterone lawsuits are targeting multiple manufacturers of testosterone products.
In June of 2014, federal testosterone lawsuits were grouped into multidistrict litigation (MDL) in the US District Court for the Northern District of Illinois, supervised by Judge Matthew F. Kennelly. The plaintiffs’ attorneys predict that thousands of testosterone lawsuits will be filed for complaints such as heart attack, stroke, cancer and other disorders and impairments.
Attorneys for the plaintiffs claim that the manufacturing companies have failed to adequately warn of possible side effects and that testosterone is aggressively marketed to aging men, encouraging its use so much that only two percent of men using testosterone actually have a medical condition causing low testosterone.