Testosterone therapy, which is used my millions of men, can lead to serious heart-related side effects, including heart attacks.
For men suffering from low testosterone, known as Low T, hormone replacement therapy drugs can help regulate hormone levels in the body and provide relief from a number of symptoms like fatigue, low sex drive and weight gain. What most of these men might not know, however, is that drugs like AndroGel can come with health risks. One of the most serious is an increased risk of heart attack.
A number of studies link testosterone replacement therapy (TRT) to an increased risk of cardiovascular problems. These studies caught the attention of the FDA, which issued a safety alert stating that it will investigate these findings to determine whether new labeling on products is in order. Additionally, the agency reiterated its official position on these products, reminding consumers and doctors that they should be prescribed only in proven cases of low testosterone and only when patients have symptoms.
Some doctors, including Dr. Bradley Anawalt of the Hormone Health Network, warn patients about Low T clinics that administer drugs without properly testing patients.
“They are sex hormone factories,” Anawalt told PBS. “What I mean by that is: They are out to promote all the potential virtues and great myths about how testosterone may solve all problems. And they’re really out to prescribe as much testosterone as they possibly can, and it’s not clear that all these practices are completely safe.”
Studies Link Testosterone to Heart Attacks
One testosterone study published in January 2014 found increased heart attack risk in men who used testosterone. The risk did not only apply to older men. But men young than 65 with pre-existing heart disease had “a twofold increase in risk of nonfatal heart attack shortly after initiation of testosterone therapy,” according to the study.
The study’s author, epidemiologist William Finkle, told NPR “the risk of heart attack should be added to the discussion between patients and physicians.”
Finkle’s study involved the records of 55,000 men prescribed testosterone in the Unites States. It found that in the first 90 days of beginning hormone therapy, 1 in 167 men aged 65 or older could suffer a heart attack, while 1 in 100 men under 65 with pre-existing heart disease may have one.
Other earlier studies also revealed an increased risk of cardiovascular issues. A smaller 2010 study published in the New England Journal of Medicine revealed “the risk of a cardiovascular-related adverse event remained significantly greater among men in the testosterone group than among men in the placebo group.” Another study from the same year was canceled because of the potentially high cardiovascular risk to subjects.
“We have a 2010 study that was canceled because of unexpected cardiovascular risk,” Finkle told NPR. “I think that was sufficient to justify a warning. Why withhold that from the patient?”
Another study from November 2013 found an increase in the rate of heart attacks and other cardiovascular issues in veterans who took the hormone replacement drugs versus those who did not.
Calls for a Black-Box Warning
The risk of cardiovascular problems has led consumer advocacy groups to call for a black-box warning on all testosterone drug packaging. Dr. Sidney Wolfe of Public Citizen said that the organization petitioned the FDA to require manufacturers to add warnings to the packages of several hormone replacement products already on the market.
“[Previous studies] showed that there was a 50 percent increase in cardiovascular risk . . . 14 studies that weren’t funded by the drug industry [showed] over a doubling of risks,” Wolfe told Drugwatch. “The FDA is part of the public health service. It is doing the public no health service to make conclusions like that, and de facto encourages more of this massive use – we would argue misuse for most people – of testosterone products.”
Men File Lawsuits Against Testosterone Manufacturers
The issue of testosterone and side effects related to the heart made its way into the courts. Four days after the FDA issued its testosterone safety alert in early 2014, five men ranging in age from 50 to 63 filed lawsuits in a federal court in Chicago against Abbott Laboratories and its spin-off company, AbbVie Inc, makers of a testosterone replacement drug called AndroGel.
Their complaint detailed claims that three of the men had had heart attacks after using AndroGel, that one had had a stroke and that another had suffered a mini-stroke. The plaintiffs also allege that these companies deceived consumers, using aggressive and deceptive marketing practices that stressed the benefits of the drug and exaggerated the need for it while downplaying known, serious adverse health effects.