Testosterone Therapy Side Effects

Testosterone replacement therapy is approved to treat hypogonadism but may cause serious side effects. Men who received testosterone for “low-T” treatment may have been unnecessarily placed at increased risk for blood clots, pulmonary embolism, heart attack, stroke and other potentially fatal testosterone therapy side effects.

testosterone-litigation-seegerTestosterone 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:

  • Acne
  • Oily skin
  • Increased body hair and facial hair growth
  • Aggressive tendencies
  • Weight gain
  • Increased sex drive
  • Headache
  • Hot flushes

Moderate Testosterone Side Effects

Some side effects may be more damaging to the quality of life such as:

  • Gynecomastia
  • Headache
  • 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

Testosterone replacement therapy may cause a number of side effects that can result in more dangerous conditions such as heart attack, coronary artery disease, pulmonary embolism, stroke, and death.

Some of the side effects that contribute to those serious medical conditions include:

  • Hypertension or high blood pressure
  • Difficulty breathing
  • Sleep Apnea
  • Weight gain
  • Edema
  • 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.

Testosterone Lawsuits

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.

View Sources

  1. Allday, Erin. (15 August 2012). Testosterone builds muscle but has risks. SFGate. Accessed on 26 August 2014. http://www.sfgate.com/giants/article/Testosterone-builds-muscle-but-has-risks-3791601.php
  2. Andriote, J.(5 April 2013) Should the modern man be taking testosterone. The Atlantic. Accessed on 26 August 2014. http://www.theatlantic.com/health/archive/2013/04/should-the-modern-man-be-taking-testosterone/274663/
  3. Barqawi, A., Crawford, E. (2006). Testosterone replacement therapy and the risk of prostate cancer. Is there a link? International Journal of Impotence Research. Accessed on 26 August 2014. http://www.medscape.com/viewarticle/540617_2
  4. Basaria, M,. et al. (8 July 2010) Adverse Events Associated with Testosterone Administration. New England Journal of Medicine. Accessed on 26 August 2014. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3440621/
  5. Dubowitz, N., Fugh-Berman, A. (15 September 2013) Outside Opinion: Testosterone treatments are dangerous for men. Chicago Tribune. Accessed on 26 August 2014. http://articles.chicagotribune.com/2013-09-15/business/ct-biz-0915-outside-opinion-con-20130915_1_low-testosterone-levels-androgel-heart-attacks
  6. Finkle, W., et al. (29 January 2014). Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLOS One. Accessed on 26 August 2014. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805
  7. Food and Drug Administration (2009) Postmarket Reviews: Topical Testosterone Gel Products, US FDA. Accessed on 26 August 2014. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm189806.htm
  8. Food and Drug Administration (31 January 2014) Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. US FDA. Accessed on 26 August 2014. http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?utm_source=rss&utm_medium=rss&utm_campaign=fda-evaluating-risk-of-stroke-heart-attack-and-death-with-fda-approved-testosterone-products
  9. Food and Drug Administration (19 June 2014) FDA adding general warning to testosterone products about potential for venous blood clots, US FDA. Accessed on 26 August 2014. http://www.fda.gov/drugs/drugsafety/ucm401746.htm
  10. Glueck, C., et al, (20 April 2014), Testosterone therapy, thrombophilia-hypofibrinolysis, and hospitalization for deep venous thrombosis-pulmonary embolus: an exploratory, hypothesis-generating study, Clinical and Applied Thrombosis/Hemostasis, Accessed on 26 August 2014 http://www.ncbi.nlm.nih.gov/pubmed/23925401
  11. Freiden, J. (26 August2010). Testosterone gel linked to risk of MI and stroke. Medpage Today. Accessed on 26 August 2014. http://www.medpagetoday.com/Cardiology/Atherosclerosis/20990
  12. Gaylis, F., et al. (August 2005). Prostate cancer in men using testosterone supplementation. Journal of Urology. Accessed on 26 August 2014. http://www.ncbi.nlm.nih.gov/pubmed/16006887
  13. Healy, M. (29 January 2014). Testosterone prescriptions linked to heart attack. Los Angeles Times. Accessed on 26 August 2014. http://www.latimes.com/science/sciencenow/la-sci-sn-testosterone-heart-attack-20140129-story.html
  14. JAMA Release. (5 November 2013).Testosterone Therapy Following Coronary Angiography Associated With Increased Risk Of Adverse Outcomes. JAMA Network. Accessed on 26 August 2014. http://media.jamanetwork.com/news-item/testosterone-therapy-following-coronary-angiography-associated-increased-risk-adverse-outcomes/
  15. National Institutes of Health. (2014). Testosterone topical. Accessed on 26 August 2014. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a605020.html
  16. Rettner, R. (4 June 2013). Testosterone therapy prescriptions have tripled for men trying to treat ‘Low T.’ Huffington Post. Accessed on 26 August 2014. http://www.huffingtonpost.com/2013/06/04/testosterone-therapy-prescriptions-low-t_n_3384050.html
  17. Shehzad, B., et al (8 July 2010), Adverse events associated with testosterone administration, New England Journal of Medicine, Accessed on 26 August 2014. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3440621/
  18. Silverman, E. (29 January 2014). Low T or High Risk? Testosterone Treatments and Heart Attacks. Forbes. Accessed on 26 August 2014. http://www.forbes.com/sites/edsilverman/2014/01/29/low-t-or-high-risk-testosterone-treatments-and-heart-attacks/
  19. Singer, N. (23 November 2013). Selling that new man feeling. New York Times. Accessed on 26 August 2014. http://www.nytimes.com/2013/11/24/business/selling-that-new-man-feeling.html?pagewanted=2&_r=2&adxnnlx=1391188730-DE5Tbi8JmidXxcTxWxpKKQ&
  20. Surampudi, P., Wang, C., Swerdloff, R. (7 December 2011). Hypogonadism in the aging male diagnosis, potential benefits, and risks of testosterone replacement therapy. International Journal of Endocrinology. Accessed on 26 August 2014. http://www.hindawi.com/journals/ije/2012/625434/
  21. Vigen, R., et al. (6 November 2013). Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. Journal of the American Medical Association. Accessed on 26 August 2014. http://jama.jamanetwork.com/article.aspx?articleID=1764051
Have you been affected by a drug or device listed? Call 855-543-7559