Testosterone therapy risks, and a lack of desirable effects, have been demonstrated in recent studies, prompting FDA investigation and updated warnings.
Although testosterone drugs are marketed to men as products improving sexual function and quality of life, health experts have long been concerned about their effectiveness. Studies have linked testosterone drugs Androderm and AndroGel to increased risk of heart attack and stroke in men, while showing little evidence that they provide any benefits. A recent 2015 study, for example, examined a group of men taking testosterone replacement therapy and a control group taking a placebo for three years, and found little difference between results for the two groups. Study Finds Testosterone Gel Adds No Significant Benefit in Men’s Lives Researchers from Harvard examined data from 308 men 60 years or older who had low or low-to-normal testosterone levels. In this study, a total of 42 percent had hypertension, 25 percent had diabetes, 15 percent had cardiovascular disease, and 27 percent were obese. Participants were recruited from three different U.S. health centers, between 2004 and 2009. Researchers gave 156 men 7.5 grams of one percent testosterone and 152 placebo gel packets daily for three years. At the end of that time, they found the following: • Measurements of the arterial walls (atrial wall thickening is a sign of cardiovascular disease) were not significantly different between the two groups. • The rate of change in the coronary artery calcium score (which shows the rate of calcium buildup on artery walls) was not significantly different between the two groups. • Overall sexual function scores, which included measurements of sexual desire. erectile function, and partner intimacy, were not significantly different between the two groups. • Health-related quality of life was no different between the groups. Researchers concluded that testosterone levels did not help men with sexual dysfunction, sexual desire, or quality of life. The researchers also emphasized that though the testosterone did not affect arterial thickness or buildup, that the results should “not be interpreted as establishing cardiovascular safety of testosterone use in older men.” 2013 Study Raises Concerns About Testosterone Therapy That same journal published a study in 2013 that looked at the way testosterone replacement drugs may affect cardiovascular health. Researchers looked at over 1,000 men who started testosterone therapy after a coronary angiography (an x-ray that checks the condition of the coronary arteries). The results were as follows: • At 3 years after coronary angiography, 19.9 percent of men not taking testosterone drugs suffered a cardiovascular event (like a heart attack or stroke), while 25.7 percent of men taking testosterone suffered similar events. • Analysis of the results showed that 5.8 percent more men taking testosterone drugs suffered cardiovascular events, compared to men not taking the results. The results were so concerning that the scientists stopped the study prematurely, “due to adverse cardiovascular events raising concerns about testosterone therapy safety.” Increased Awareness Leads FDA to Investigate Cardiac Risks Associates with Testosterone Products Other studies have found similar results, and in 2014, the FDA released a safety communication stating they were investigating the safety of these drugs. In March 2015, the FDA announced that testosterone therapy drugs had been updated to include warnings about a potential link between the drugs and heart problems. With the release of these studies and FDA warnings and label change, awareness increased about potential testosterone therapy risks. Now, a number of testosterone lawsuits have been filed around the nation. In June 2014, all federal cases were consolidated into one court in the Northern District of Illinois. Originally posted by Eric T. Chaffin on LegalExaminer.com. Testosterone Therapy Risks – Ball & Bonholtzer Trial Attorney – Los Angeles