Many men who experience fatigue, decreased sexual virility and other signs of aging turn to testosterone replacement treatments like Testim and AndroGel to help reverse the natural decline of testosterone, thereby improving sex drive, building muscle mass and increasing bone density. However, mounting research has identified an increased risk of life-threatening side effects, like heart attack and stroke, among older men with pre-existing heart conditions receiving testosterone therapy, and even among young men with no prior heart problems. If you have undergone testosterone replacement therapy, and you have since suffered a potentially fatal side effect, like heart attack or stroke, consult an experienced attorney today to discuss your legal options. You may have grounds to file a testosterone therapy lawsuit against the drug manufacturing company, in order to pursue financial compensation for your losses.
The amount of testosterone naturally produced by the male body begins to decrease around the age of 40, and many older men struggle at this point with health issues like osteoporosis, psychological symptoms, and a loss of muscle mass and coordination. Some of these men turn to testosterone therapy to improve their sex drive and treat erectile dysfunction, and once hormone replacement therapy is initiated, the patient usually undergoes lifelong treatment. However, in light of the risk of potentially life-threatening side effects that have been linked to popular low-T drugs, many older men are looking for safer alternatives to hormone replacement therapy to treat low testosterone levels, including the following natural testosterone boosters:
January 2014 – The FDA issues a safety announcement indicating that it is “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” The agency also warns that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”
February 2014 – The consumer advocacy group Public Citizen urges federal regulators to add a black box warning to the labels of testosterone products, warning about the risk of cardiovascular side effects.
April 2014 – The European Medicines Agency launches a review of testosterone replacement therapy, demanding marketing information from the manufacturing companies.
June 2014 – The FDA issues a safety communication requiring the makers of testosterone products to include warnings on their drug labels about the risk of blood clots in the veins, known as venous thromboembolism.
July 2014 – Health Canada warns about a “growing body of evidence” tying testosterone products to heart problems, including heart attack, stroke, blood clots in the legs or lungs, and an irregular heart rhythm.
September 2014 – An FDA report published ahead of an advisory panel meeting indicates that there is little evidence of any benefit from TRT in aging men, and that the safety risks are unclear.
September 2014 – An FDA panel votes in favor of restricting the labels of testosterone products, indicating that the drugs are only intended for patients diagnosed with hypogonadism.
April 2015 – A safety communication released by the FDA asks the makers of testosterone treatments to stop marketing the products for age-related “Low T,” begin studying the long-term risks of the products, and add warnings to the labels about the risk of heart attacks and strokes.
August 2005 – The Journal of Urology publishes research suggesting that men undergoing testosterone treatment may be at risk of developing prostate cancer within months to a few years after beginning TRT therapy.
June 2010 – A study published in the New England Journal of Medicine indicates that older men with limitations in mobility and a high prevalence of chronic disease are more likely to suffer heart attacks and other major cardiac events from testosterone treatment. During the study, one man died from what researchers say was likely a heart attack brought on by testosterone use.
April 2013 – The journal Clinical and Applied Thrombosis/Hemostasis publishes a study indicating that blood clots may develop as soon as one month after beginning testosterone replacement therapy.
April 2013 – A study published in the journal BioMed Central suggests that low-T treatments increase the risk of cardiovascular-related events in users.
June 2013 – A study published in JAMA Internal Medicine indicates that, between 2001 and 2011, the use of low-T treatments among men ages 40 and older increased more than three-fold. According to the researchers, by 2011, nearly one in 25 men in their 60s, and nearly one in 40 men in their 40s, were taking some form of hormone replacement therapy.
June 2013 – Dr. Adriane Fugh-Berman of Georgetown University Medical Center tells USA Today that testosterone replacement therapy “offers no proven benefits for healthy men,” adding that “Low T syndrome is invented by pharmaceutical companies to sell treatment products.”
November 2013 – The Journal of the American Medical Association publishes a study indicating that men aged 60 and older using low-T drugs may have a 30% increased risk of stroke, heart attack and death.
November 2013 – Addressing the practice of drug companies marketing hormone replacement therapies for off-label uses, Dr. Lisa Schwartz, professor at the Dartmouth Institute for Health Policy and Clinical Practice, tells the New York Times, “We’re giving people hormones that we don’t know they need for a disease that we don’t know they have, and we don’t know if it’ll help them or harm them.”
January 2014 – Research conducted by UCLA and the National Cancer Institute, and published in the medical journal PLoS One, finds that men over the age of 65, and younger men with pre-existing heart disease, have a two-times increased risk of suffering a heart attack after the first 90 days of TRT.
April 2014 – A professor at the University of Washington Harborview Medical Center publishes an editorial in The Lancet Diabetes & Endocrinology, calling for new clinical trials studying the safety and effectiveness of testosterone therapy.
October 2014 – A study led by Professor Maarten Bosland from the University of Chicago’s College of Medicine indicates that rats exposed to a carcinogen did not develop cancer, while 10-18% of rats exposed to testosterone did.
January 2015 – The journal Pharmacotherapy publishes a study linking first-time use of testosterone products to a 41% greater risk of heart attack, compared to non-users, and higher risks for men with coronary artery disease.
May 2015 – A study published in the Journal of the American Medical Association suggests that testosterone injections, like Depo-Testosterone, may increase a man’s risk of suffering stroke, heart attack or death, compared to topical gels like AndroGel, which are absorbed slowly through the skin.
August 2015 – The Journal of the American Medical Association publishes research indicating that testosterone therapy does not appear to improve sexual health or overall quality of life.
Since 2000, more than one million men have had their testosterone levels tested, and half a million began using testosterone replacement therapy. Today, four times as many men are using low-T medications than in 2000, and this has raised red flags about the possible risks of off-label testosterone treatment. At the same time, while side effects of testosterone replacement therapy are more frequently noted in patients over the age of 65, more and more cases are arising in which young men are suffering severe complications after undergoing TRT. In light of these findings, a growing number of product liability lawsuits are being brought against the makers of testosterone products, alleging that:
More than five million prescriptions have been written in the United States for testosterone treatments, and, as more men become aware of the potential health risks associated with testosterone therapy, victims are holding the manufacturers of these prescription drugs accountable for their products. If you or a loved one has been adversely affected by side effects of testosterone replacement therapy, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a reputable lawyer who has experience handling testosterone treatment lawsuits. With a qualified attorney on your side, you can protect your legal rights and seek fair and timely reimbursement for your injuries, medical expenses, and pain and suffering.