First-Time Testosterone Drug Users Face Increased Heart Attack Risk: Study

The findings of a new study seems to provide support for the growing number of Androgel lawsuits and other testosterone drug lawsuits being filed throughout the U.S., indicating that first-time users of the popular “low T” treatments face an increased risk of suffering a heart attack. 

Researchers from the University of British Columbia found that first-time users of testosterone replacement therapy (TRT) are 40% more likely to have a heart attack than men who do not use the drugs.

The findings were published in the medical journal Pharmacotherapy on January 13, following an evaluation of data on nearly 1 million men from ages 45-80. While the researchers did not find a statistically significant increase in heart attack risk among current testosterone drug users, those classified as first-time users were 41% more likely to have a myocardial infarction (MI), or heart attack.

“In this large observational study, an association between MI and past or current TRT use was not found,” the researchers noted. “However, a statistically significant association was observed between first-time TRT exposure and MI, although the absolute risk was low.”

The study is the latest in an ongoing debate over the the potential heart side effects of testosterone drugs, following the publication of several studies over the past year that suggest certain users of the popular medications may face an increased risk of heart attacks, strokes and sudden death.

In September, a panel of independent advisors to the FDA reviewed the available data surrounding the widely used and aggressively marketed “low T” drugs, and concluded that that there is currently insufficient data to reach a conclusion about the link between testosterone drugs and heart attacks. However, the panel did determine that the medications are widely overused and recommended the FDA limit use and require additional studies by manufacturers.

Many of the prescriptions for low testosterone treatments in recent years have been given to men who do not suffer from medically proven hypogonadism, usually caused by disease or injury affecting the testicles or certain parts of the brain. Several studies have suggested that a large portion of men given the drugs have no medical need, but rather are prescribed the drugs for “lifestyle reasons”, treating the natural declines in testosterone levels as all men age.

The widespread overuse of the medications may needlessly expose men to a risk of heart attacks and other problems from testosterone drugs, leading many experts to recommend against such use.

Testosterone Health Risks

Over the past decade, low T drugs like Androgel, Axiron, Testim and others have grown to generate more than $2 billion in annual sales.

In 2013, concerns emerged about the potential heart risks with testosterone drugs, following the publication of studies that suggested certain users may be more likely to suffer a heart attack, stroke, blood clots or sudden death.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

Throughout the United States, a growing number of men are now pursuing product liability lawsuits against the makers of testosterone replacement therapy, alleging that they recklessly promoted the medications without adequately warning consumers and the medical community about the potential risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis and other potentially life-threatening injury.

In the federal court system, the testosterone litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Illinois, where all cases are centralized before U.S. District Judge Matthew Kennelly to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

The first testosterone drug trials are expected to begin in late 2016, involving claims filed against AbbVie over their Androgel treatment, which is the most widely used low T drug. While the outcomes of these early trials are not binding on other cases, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, and may facilitate testosterone settlements or another resolution for the cases.