Testosterone is a natural hormone produced in both women and men, but in higher concentrations in men. Testosterone therapy, also known as androgen replacement therapy, is the use of synthetic testosterone supplementation to treat certain conditions or symptoms. The main reason for using this therapy is to treat male hypogonadism, or low levels of testosterone, which may be caused by any number of conditions.
In recent years men have also been treated with testosterone to treat certain symptoms which may or may not be caused by low testosterone, like sexual dysfunction and fatigue. Many drug companies make testosterone products and are making big money by aggressively advertising to older men. The problem is that more men may be using this medication than is necessary, and there are risks, including heart attack and stroke. Several lawsuits have already been filed by patients and their families because of these devastating side effects.
What is Testosterone?
Testosterone is a natural hormone, called an androgen, or a male sex hormone. This steroid hormone is produced mostly in the testes in men, but also to a smaller extent in ovaries in women and in the adrenal glands in both men and women. For men, testosterone is important in developing reproductive organs and tissues during puberty.
Throughout a man’s life testosterone is important for maintaining a proper distribution of fat throughout the body, muscle mass and strength, bone strength and density, and sex drive. It also plays a role in producing red blood cells, sperm, and facial and body hair. As men get older, levels of testosterone naturally decline. Peak levels are seen in adolescence and the early adult years. After that it is typical to lose about one percent of testosterone production each year
Male Hypogonadism
Although it is natural to lose testosterone as you age, some men may experience an unnatural loss of testosterone. Lower than normal levels of testosterone is called male hypogonadism, sometimes also called just low testosterone or low T. The only real way to know if a man has low T is to do a blood test to measure testosterone levels in the body.
Physical symptoms of low testosterone in adult men include erectile dysfunction and infertility, loss of body or facial hair, gynecomastia, the enlarging of the breasts, loss of bone mass and density, and loss of muscle mass. Other symptoms that may accompany hypogonadism include fatigue, a loss of sex drive, hot flashes, and trouble concentrating. These are similar to the symptoms women experience during menopause.
There are several possible causes for low testosterone in a man. If it is primary hypogonadism, a defect in the testicles, it could be caused by injury or damage to the testicles, a mumps infection, chemotherapy, undescended testicles, or a chromosomal condition called Klinefelter syndrome. Secondary hypogonadism is due to a problem with the glands that trigger testosterone production and can be caused by certain infections, like HIV, obesity, certain medications, disorders of the pituitary gland, or simply aging.
Testosterone Therapy
Hypogonadism is typically treated by finding and treating the underlying condition causing it, but testosterone replacement therapy is also likely to be a part of the treatment. Supplementing with testosterone can relieve the symptoms while the underlying condition is addressed. Testosterone therapy is usually administered by injection, by using a patch, or by applying a gel to the skin.
Popular testosterone gels include AndroGel and Testim. Depo-testosterone is a typical injectable form of the therapy. Androderm is the name for the patch that delivers testosterone. Other forms of testosterone, like pellets implanted under the skin or capsules placed in the mouth, include Testopel, Striant, Android, and Testofen.
Testosterone replacement products are approved for use only in men with diagnosed hypogonadism, regardless of what the underlying cause is. It is not supposed to be used for men who only have symptoms of low T (without being tested for hypogonadism) or who have normal low levels of testosterone due to aging. Doctors are allowed to prescribe these medications at their own discretion, however, for off-label use.
Side Effects of Testosterone
The most common side effects of testosterone replacement therapy include mood swings, high blood pressure, increased red blood cells, skin irritation with gel application, longer and more frequent erections, and an increase in prostate specific antigen, which is used to test for prostate cancer.
Other, more serious, side effects include a worsening of prostate enlargement. Signs of this include urinating more at night, trouble starting urination, frequent urination, or having a weak urine flow or difficulty passing urine. There is a slightly increased risk of developing prostate cancer, edema, enlarged breasts, and a lower sperm count.
Women and children are not supposed to use testosterone products and should not even come in contact with them. Even accidental contact can cause signs of early puberty in children and changes in women, which include more pubic hair, enlarged sex organs, aggression and increased sex drive.
The Risk of Clots, Heart Attack, and Stroke
There are several possible side effects of using testosterone therapy, but for men with genuine cases of hypogonadism the benefits are often worth the risks. More recent research, though, has uncovered some risks that may not be worth the benefits. Testosterone therapy is now known to increase the risk of the formation of blood clots, which in turn increases the risk of having a heart attack or stroke.
One study even finished early because the researchers noticed that the older men in the study who were on testosterone therapy had significantly more heart problems than the control group. A study from 2013 found that men with hypogonadism and using testosterone therapy were having more adverse outcomes, including heart attacks and strokes, than men in a control group.
Direct-to-Consumer Marketing
A point of controversy in the surge of testosterone use is the aggressive kind of marketing that drug companies engage in when it comes to their low-T products. The FDA regulates how drug manufacturers can market products, but a loophole in these regulations means that they can urge men to talk to their doctors if they have possible signs of low testosterone.
The problem with this is that many of the signs are common in men as they age and likely have nothing to do with testosterone levels. For instance, some of the direct-to-consumer ads have urged men to talk to their doctors about low T if there are tired or fatigued. This could be a sign of anything from insomnia to depression to stress. The aggressive nature of the advertising has led many more men to request testosterone therapy from their doctors than ever would have in the past.
Symptoms of Low Testosterone or Natural Aging?
The type of advertising and marketing in which the drug companies making testosterone products has engaged is considered by some to be unethical. Few men are diagnosed with hypogonadism, or low testosterone, and yet men are taking testosterone in record numbers according to a recent study.
Many men who are prescribed a testosterone therapy are simply trying to treat natural signs of aging, like changes in sexual function and energy. The only real way to know if a man has clinically low levels of testosterone and requires therapy is by doing a blood test.
Lawsuits
One of the biggest concerns with testosterone products is the risk of heart attack and stroke. Other risks have long been known and are not serious for most men. Lawsuits have been filed against some of the companies that make testosterone therapy products, including AbbVie and Abbott Laboratories, the makers of AndroGel. Several individuals reported having heart attacks, strokes, or blood clots and are suing for damages.
Although the FDA has recently required that testosterone labels include warnings about heart attack and stroke risks, and has stated that the therapy is not to be prescribed to men for aging-related low T, hundreds or thousands of men have already suffered the negative consequences of using testosterone when they didn’t really need it. Thanks to the aggressive marketing by drug companies and the lack of information about risks, too many men have experienced unnecessary side effects and the drug makers may be paying up soon as a result.
Sources
- http://www.mayoclinic.org/diseases-conditions/male-hypogonadism/basics/treatment/con-20014235
- http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255313.pdf
- https://www.nlm.nih.gov/medlineplus/druginfo/meds/a605020.html
- http://www.mayoclinic.org/healthy-lifestyle/sexual-health/in-depth/testosterone-therapy/art-20045728
- http://www.health.harvard.edu/mens-health/is-testosterone-therapy-safe-take-a-breath-before-you-take-the-plunge
- http://www.hindawi.com/journals/ije/2012/625434/
- http://www.nytimes.com/2013/11/24/business/selling-that-new-man-feeling.html?_r=0