Testosterone Replacement Therapy (TRT) products for men have been linked to an increased risk of death, heart attack and stroke. Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use.
Furthermore, men who started the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease.
Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have a deficiency of the male hormone. Symptoms of low testosterone include decreased libido and low energy.
What is testosterone?
Testosterone is a male hormone that plays an important role in sexual and reproductive development. In men, testosterone is produced mainly in the testes and spurs the development of secondary sex characteristics at puberty, including voice deepening, increased penis and testes size, and growth of facial and body hair. It also is involved in sex drive, sperm production, fat distribution, red cell production, and maintenance of muscle strength and mass.
Levels of testosterone generally peak during adolescence and early adulthood, and gradually decline around age 30 or 40.
What is low testosterone?
Low testosterone occurs when men’s bodies do not produce enough testosterone, or have an impaired ability to produce sperm, or both. It is referred to in the medical community as hypogonadism.
Some men are born with hypogonadism. Others can develop it later in life often from injury or infection. Adult men with hypogonadism may experience symptoms such as erectile dysfunction, infertility, decrease in body hair, decrease in muscle mass, and loss of bone mass. It may also decrease sex drive, and cause hot flashes and fatigue. Testosterone replacement therapy may be used as a treatment for men with hypogonadism.
As men age, they experience a natural drop in testosterone. Age-related hypogonadism is not an indication for testosterone replacement therapy, and some studies suggest that men who use testosterone therapies in search of the “fountain of youth,” may experience serious cardiovascular side effects and other health issues.
Deceptive marketing and Low T
Manufacturers of testosterone replacement therapies heavily marketed their products directly to consumers, even encouraging them to ask their doctors if they are a candidate for testosterone treatment. Some drugmakers also created a condition called “Low T,” with symptoms such as low sex drive, muscle loss, weight gain and mood swings, and promoted their testosterone products as treatments.
Drug companies paid millions to promote their drugs as treatments for so-called Low T. According to Kantar Media, AbbVie paid more than $75 million to promote AndroGel to consumers in 2012, and nearly $68 million in 2013. As a result of these aggressive marketing practices, sales of testosterone products skyrocketed.
In March 2015, the Food and Drug Administration (FDA) issued a Drug Safety Communication cautioning that prescription testosterone products are approved “only for men who have low testosterone levels caused by certain medical conditions,” and not by age-related hypogonadism because the safety and efficacy for this use had not been evaluated. The agency required testosterone manufacturers to update the safety labels of their products to reflect this clarification in prescribing.
At that time, the FDA also ordered testosterone makers to add warnings about an increased risk of cardiovascular events, including heart attacks and strokes.
Testosterone side effects
The use of testosterone replacement therapy has been linked to serious adverse events including heart attack, stroke, blood clots (which can lead to deep vein thrombosis and pulmonary embolism) and death, including sudden cardiac death.
- A 2009 study from Boston Medical Center and published in the New England Journal of Health was abruptly halted after finding that older men with limited mobility treated with testosterone therapy were at greater risk of developing adverse cardiovascular events such as heart attacks and elevated blood pressure.
- A 2014 study published in the journal PLOS ONE found that men age 65 years and older had a two-fold increased risk of heart attack in the first 90 days of initiating testosterone treatment. The same study also found that younger men with a history of heart disease had a two- to three-fold increased risk of heart attack in the first 90 days of treatment.
- A 2017 study published in the JAMA found that testosterone treatments increased coronary artery plaque buildup, which narrows coronary arteries, decreasing blood flow to the heart and lead to heart attack.
In March 2015, the FDA warned in a Drug Safety Communication that taking prescription testosterone replacement therapies could increase the risk of heart attacks and strokes and warned users of the products to seek immediate medical attention if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one side of the body, or slurred speech.
Other testosterone side effects include sleep apnea, prostate and breast growth, and prostate cancer.
Manufacturers of testosterone replacement therapies are facing thousands of lawsuits from men who believe they suffered heart attacks, strokes, or blood clots after taking products like AndroGel, Axiron and Testim.
The lawsuits allege testosterone makers misrepresent their products as safe and effective, and failed to adequately warn consumers or their doctors of the risks associated with use of these drugs. They also claim that the drug companies used aggressive marketing campaigns to promote their testosterone treatments for unapproved conditions, like so-called Low T.
In June 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated thousands of testosterone lawsuits into a multidistrict litigation. About 6,500 cases are currently pending in the Northern District of Illinois under U.S. District Judge Matthew F. Kennelly.
- July 2017, the first testosterone bellwether was tried. It involved the case of Jesse Mitchell, who blamed AbbVie Inc.’s AndroGel for causing his heart attack. Jurors awarded Mitchell $150 million in damages.
- October 2017, AbbVie was order to pay a $140 million to Jeffrey Konrad who claimed AndroGel caused his heart attack.
- November 2017, no damages were awarded to a man who claimed he suffered a heart attack after taking Endo and Auxilium’s Testim.
- December 2017, an Illinois judge threw out Jesse Mitchell’s $150 million verdict against AbbVie, later scheduling a retrial. Eli Lilly also reached a tentative settlement agreement for more than 400 cases involving its testosterone therapy Axiron.
- January 2018, a jury sided with AbbVie in the sixth bellwether trial.
- February 2018, Endo International, Auxilium and GlaxoSmithKline reached tentative settlements in about 500 of cases they faced over their testosterone products.
- In March 2018, the retrial of Jesse Mitchell’s case against AbbVie resulted in a $3.2 million verdict in his favor.
Men who have used prescription testosterone replacement therapy and suffered a heart attack, stroke, or blood clot may have a case against the manufacturer of their product and be entitled to compensation. People who lost a family member due to sudden cardiac death, heart attack, stroke, or pulmonary embolism may also be eligible for compensation.