Testosterone Replacement Heart Attack Risk Examined in Observational Study

Amid a growing number of Androgel lawsuits and other testosterone replacement lawsuits being filed in courts throughout the country, the findings of a small observational study suggest that for a certain group of older men with pre-existing heart problems, the treatments may actually help reduce the risk of major adverse cardiovascular events.

While testosterone replacement therapy was originally expected to be a niche treatment, amid aggressive marketing of “low T” gels, creams and patches, the industry has generated more than $2 billion in annual sales in recent years.

Drugs like Androgel, Axiron, Testim, Androderm and others were originally intended only for men with confirmed testosterone deficiencies caused by a medical condition, but they have increasingly been prescribed for “lifestyle reasons”, to increase strength, stamina and reverse the natural drops in testosterone levels all men experience as they age.

Over the past two years, concerns about testosterone replacement heart risks have emerged, following publication of several studies that suggest the medications may cause certain users to face an increased risk of heart attacks, strokes, deep vein thrombosis, pulmonary embolism and other injuries. This led the FDA to require , urging doctors to only prescribe the drugs for men with a true medical need.

In this latest study, which was presented at the at the American College of Cardiology’s 65th Annual Scientific Session on April 3, researchers at the Intermountain Medical Center in Salt Lake City observed 755 male patients between the ages of 58 and 78, who all had severe coronary artery disease. They were then broken into three groups; one given no testosterone, and two other groups given high or low testosterone doses.

Researchers concluded that older men with low levels of testosterone may suffer fewer adverse cardiovascular events if given testosterone replacement, but they cautioned against calling their findings definitive. The study has not yet been peer-reviewed or published.

“Although this study indicates that hypo-androgenic men with coronary artery disease might actually be protected by testosterone replacement, this is an observational study that doesn’t provide enough evidence to justify changing treatment recommendations,” Dr. Brent Muhlestein, co-director of cardiovascular research at the Intermountain Medical Center Heart Institute, said in a press release. “It does, however, substantiate the need for a randomized clinical trial that can confirm or refute the results of this study.”

Lawsuits Over Testosterone Heart Risks

There are currently nearly 3,500 product liability lawsuits pending throughout the federal court system involving men who suffered severe and often fatal cardiovascular problems after receiving testosterone replacement therapy.

The testosterone replacement litigation has emerged since a study was published in the Journal of the American Medical Association (JAMA) in November 2013, indicating that certain men who began taking testosterone drugs following coronary angiography may be more likely to suffer a sudden heart attack, stroke or death.

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 January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

The FDA announced awarning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between “low T” drugs and heart problems. In addition, the agency urged doctors to curb the increasing practice of prescribing testosterone drugs for so-called “lifestyle” reasons.

Given the similar allegations raised in the lawsuits, cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

As part of the coordinated proceedings, a series of Androgel trials are expected to begin between April and November 2017, which 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.

If testosterone injury settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.