Testosterone Products. According to recent studies, men who take testosterone replacement products are at an increased risk of testosterone stroke and testosterone heart attack. One testosterone drug, Androgel, warns on its label a number of testosterone side effects that include high blood pressure, blood clots in the legs, and serious issues for people who have heart, kidney, or liver disease.
Lawsuits allege that testosterone replacement drugs such as Androgel and Axiron, have contributed to heart attack, stroke or blood clots. Plaintiffs in the litigations allege that testosterone manufacturers promoted their products for “Low-T” (low levels of testosterone not due to a recognized medical condition) while neglecting to disclose heart risks. The U.S. Food and Drug Administration (FDA) announced in March 2015, that the warning label on testosterone products would be updated to include the risk of heart attack and stroke.
Testosterone products are sold under various brand names including: Axiron, Androderm, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, and Testope.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have been affected by adverse side effects of testosterone products.
Testosterone Heart Attack Studies
Various studies have revealed that treating low testosterone may improve men’s sexual function, bone density, strength, and lean muscle mass and at the same time lower cholesterol and insulin resistance. A recent Journal of the American Medical Association (JAMA) study shows that the risks outweigh the benefits. Researchers showed that men who used testosterone were 30 percent more likely to have a heart attack or stroke or to die during a three-year period than men with low hormone levels who did not take the testosterone supplements. The study had 3,000 participants who averaged 60 years-of-age. A majority of the men, both hormone users and non-users, had additional health problems including high blood pressure, unhealthy cholesterol, and diabetes.
Participants who began the research 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.
In 2009, researchers discontinued a trial of approximately 200 frail older men with a high percentage of heart disease due to a high rate of heart attacks among those taking testosterone. The trial was financially backed by the National Institute of Health (NIH). Another study, sponsored by the NIH, according to The Wall Street Journal (November 5, 2013) is studying the effects of testosterone on walking ability, fatigue, sexual function, verbal memory, hemoglobin, and plaque buildup of nearly 800 men aged 65 and older with low testosterone. The study results will not be available for at least a year.
Interestingly, studies funded by pharmaceutical companies have concluded there is no increased risk of adverse cardiovascular events associated with testosterone drugs such as Androgel.
Testosterone Therapy Risks
In October 2014, it was found that men who have low testosterone and Type 2 diabetes face a greater risk of developing atherosclerosis, (a condition where plaque builds up in the arteries), than men who have diabetes and normal testosterone levels, reports the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Authors of the study recommend that testosterone treatment should be reserved for men with clinical symptoms of hypogonadism (when the sex glands produce little or no sex hormones) and consistently low levels of testosterone.
In January 2014, a study titled “Testosterone Therapy and Myocardial Infarction” published by the Public Library of Science in conjunction with the University of Florida and the National Cancer Institute shows an association between testosterone therapy (TT) and cardiovascular disease. The researchers remarked that testosterone therapy is increasing, despite the fact that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of myocardial infarction shortly after they begin testosterone therapy is substantially increased.
FDA Warns of Heart Attack, Stoke due to Testosterone Products
The FDA reminded the public that testosterone replacement products are only approved for extremely low levels of testosterone associated with a medical condition. This category would include patients with testicular damage due to cancer treatment or infection, or patients who do not produce sufficient testosterone due to a genetic abnormality. Testosterone products are not approved for symptoms of decreased testosterone associated with normal aging.
The FDA urges patients taking testosterone replacement to seek medical attention if they develop symptoms of a heart attack or stroke, which include: chest pain, shortness of breath, weakness in one part or one side of the body, or slurred speech.