On November 6, 2013, the Journal of the American Medical Association (JAMA) reported that “a recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety.” Rates of testosterone therapy are increasing, but the effects of the therapy on cardiovascular outcomes and mortality were, until this report, largely unknown.
Researchers at the University of Texas at Southwestern Medical Center in Dallas reviewed records from more than 8,700 men with low-Testosterone (low-T) levels who underwent coronary angiography — a procedure that uses dye and X-rays to peer into heart arteries — in the Veterans Affairs system between 2005 and 2011.
Of nearly 7,500 men who did not get extra testosterone, about 1 in 5 had bad cardiovascular outcomes, including stroke, heart attack or death. In the more than 1,200 men who got testosterone, nearly 1 in 4 had those terrible problems, an increased risk of nearly 30 percent. The researchers concluded that taking testosterone came with an increased risk of an adverse outcome.
Testosterone supplements, 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. In recent years, sales of testosterone therapy drugs have skyrocketed, fueled by pricey marketing campaigns that encourage men to talk to their doctors to see if testosterone therapy is right for them. As a result, testosterone supplementation has grown to a billion-dollar industry that has increased more than five-fold from 2000 to 2011. More than 5.3 million prescriptions are written for testosterone products each year. Nearly 3 percent of all men in the United States older than 40 use the drugs.
Little was known about the long-term effects of testosterone therapy until researchers with a University of Colorado study revealed their findings. Not only did they find that men who used testosterone supplements for three years or more were at greater risk of cardiovascular problems or death, they also found other disturbing evidence.
Fourteen percent of men who started testosterone therapy after undergoing an angiography were mostly younger and slightly healthier than the 86 percent who did not use the hormones. However, after an average of three years, the men who used testosterone supplements were nearly 30 percent more likely than those who did not take the hormones to have a stroke, heart attack, or die from any cause. 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. Researchers say the study raises definite concerns about testosterone supplementation that men should discuss with their doctors.
Testim and Androgel already carry a warning to users to wash their hands thoroughly after applying the gel, and to cover the area of the body where the gel was applied because unintended exposure to women, children, and even pets has resulted in adverse reactions. For example, children who have been accidentally exposed to the gel have shown signs of premature puberty that could have long-term effects such as inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, aggressive behavior and advanced bone age.
Lawyers in our firm’s Mass Torts Section are currently investigating cases involving testosterone therapy drugs. If you or a family member have experienced any adverse affects or you need more information, contact Melissa Prickett or Matt Teague, lawyers in our firm’s Mass Torts Section, for more information at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com or Matt.Teague@beasleyallen.com.
Sources: The Journal of the American Medical Association, ABC News and NBC News
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