Risk of Testosterone Therapy Heart Problems Questions By Study

A new study appears raises questions about the risk of heart problems from testosterone therapy side effects, adding to a number of contradictory studies about the widely used “Low T” drugs, such as Androgel, Axiron, Testim and others. 

In the latest edition of the medical journal Mayo Clinic Proceedings, researchers indicate that higher testosterone levels may actually reduce the risk of cardiovascular problems. However, the findings conflict with a number of other studies that have suggested there is a potential link between testosterone and heart problems for some men.

Researchers conducted an analysis of studies dating back to 1940 on testosterone heart risk and determined that a majority of studies have found that increasing testosterone levels lower heart risks.

“[S]everal dozen studies have reported a beneficial effect of normal T levels on CV risks and mortality,” the researchers concluded. “Testosterone therapy is associated with reduced obesity, fat mass, and waist circumference and also improves glycemic control.”

The lead study author, Dr. Abraham Morgentaler, is a founder of the Androgen Study Group, which has actively worked to refute concerns about testosterone drug risks.

Morgentaler has served on the science board for Auxilium, the makers of the popular testosterone drug Testim, and co-author Martin Miner has also worked as an Auxilium consultant.

The findings come just days after a group of independent 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. Those findings were published on January 13 in the medical journal Pharmacotherapy.

Testosterone Heart Risks

The conflicting studies are the latest in an ongoing debate over the the potential heart risks with testosterone therapy, 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 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.

In response to an FDA investigation, a panel of independent advisors to the agency was convened in September to review the available data surrounding the widely used and aggressively marketed “low T” drugs. The FDA advisory panel concluded that that there is currently insufficient data to reach a conclusion about the cardiovascular risk with testosterone therapy. However, the panel did determine that the medications are widely overused and recommended the FDA limit use and require additional studies by manufacturers.

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

Many of the prescriptions for low testosterone treatments 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 Therapy Lawsuits

Amid the continuing questions about the drugs and concerns about why the drug makers did not adequately study the potential side effects f the medications, a growing number of men throughout the United States are now pursuing Androgel lawsuits, Axiron lawsuits, Testim lawsuits and other testosterone therapy lawsuits, claiming that the drugs were recklessly promoted without adequate warnings about the 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.