Testosterone replacement therapy has been controversial for years, but now new trial information is adding another risk to the use of the synthetic hormone supplement. A National Institutes of Health (NIH)-funded trial recently reported that men using AndroGel, a testosterone gel, had more dangerous plaque buildup in their arteries than men receiving a placebo. More plaque equates to a greater risk of stroke and heart attack.
The AndroGel Trial
The NIH is in the process of conducting seven trials to determine how safe and effective testosterone supplements are for men. The results of one of these trials were recently published in the Journal of the American Medical Association. The study was randomized and double blind with 170 participants. The men all had low testosterone due to age, and the average age of the participants was 71.
Half of the participants were given AndroGel, a topical supplement made by AbbVie. The other half were given a placebo gel with no testosterone in it. The men who received the AndroGel had 20 percent more plaque in their arteries at the end of the trial, as compared to the men who received the placebo. Plaque is a deposit of fat, cholesterol, and other substances that builds up on the inside of arteries. This causes the arteries to thicken and harden and significantly increases the risk of having a heart attack or a stroke.
The Low T Controversy
Companies like AbbVie have been accused of pushing testosterone for men who don’t need it, putting them at risk of serious complications, such as plaque buildup. These companies advertised their products as a treatment for “Low T,” or low testosterone. This hormone naturally drops off as men age and it isn’t a health problem for most. Some men may develop dangerously low levels of testosterone and have a real medical need for supplements, but most with age-related low testosterone do not need the synthetic supplement.
Promising older men a fountain of youth, these companies put them at risk for a number of health risks of using testosterone supplements: prostate enlargement, edema, blood clots, heart attack, and stroke. A 2013 study of testosterone actually finished early because the outcomes were so poor and men using the supplements were dying at a higher rate.
Lawsuits over Testosterone Therapy
Companies like AbbVie are increasingly becoming subject to lawsuits over the adverse health effects of testosterone supplements. The companies have been accused of using aggressive marketing and enticing men to use testosterone for natural, age-related declines in the hormone. There are now more than 6,000 federal lawsuits pending against AbbVie and other companies making and selling testosterone. While the aggressive advertising has stopped, the consequences are ongoing. Bellwether trials are set to begin in June.
Studies into the safety and the risks of testosterone are ongoing and more are needed to find out just how safe or how dangerous this kind of therapy is. Currently, the risks seem high, and although there are warnings on drug labels of the risk of heart attack and stroke, some advocates believe it is not enough. Men are warned to consider testosterone therapy carefully and to avoid it unless there is a real medical need.