Testosterone Heart Risks Evaluated Between Gels, Injections, Patches in Recent Study

In response to recent concerns about the heart risk from testosterone replacement therapy, a recent study examines the safety of different types of “low T” drugs, including testosterone gels, injections and patches.

Testosterone replacement therapy has grown from a niche treatment to a $2 billion per year market in recent years, largely driven by aggressive marketing by manufacturers of testosterone gels, such as Androgel, Testim, Axiron and others. However, the drugs are also widely prescribed as injections, skin patches and in other forms.

Over the past two years, concerns have emerged about the safety of the drugs, amid widespread overuse of the treatments among men who are suffering the natural effects of agent.

Several studies that suggested certain men using testosterone replacement therapy may face an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis or other life-threatening injuries. However, the research has not distinguished between the various different dosage forms of testosterone replacement therapy.

In a recent study published in the medical journal JAMA Internal Medicine, researchers from the University of North Carolina at Chapel Hill found that side effects of testosterone injections may pose the greatest risk of cardiovascular events, hospitalizations and deaths.

Testosterone injections are known to cause spikes in testosterone levels, while transdermal patches and gels cause more subtle, but sustained, increases. Therefore, researchers set out to determine the comparative heart safety of the products.

Researchers conducted a retrospective cohort study using commercial insurance claims for men in the U.S. from 2000 through 2012, and Medicare claims from 2007 through 2010. The study also looked at general practitioner records for men in the U.K. from 2000 through 2012.

The study looked at what kind of testosterone replacement therapy was involved in the treatment, identifying those who received an injection, a patch or gels. They then looked at what happened to the men in the following 180 days.

According to the findings, which ultimately involved more than half a million men, the majority of the men, nearly 56% used testosterone gel products, like AndroGel. Just over 37% received injections, and about 7% used testosterone patches.

The findings suggest that testosterone injections were associated with a 26% higher chance of heart attack, unstable angina and stroke, a 16% higher chance of hospitalization, and a 34% increased risk of death, when compared to the use of gels and patches.

“Testosterone injections were associated with a greater risk of cardiovascular events, hospitalizations, and deaths compared with gels,” the researchers concluded. “However, this study did not assess whether patients met criteria for use of testosterone and did not assess the safety of testosterone among users compared with nonusers of the drug.”

Testosterone Heart Concerns

Concerns about the testosterone heart risks began to gain wide-spread attention in November 2013, when 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, such as a 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 a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency indicated that use of testosterone therapy should be limited to men diagnosed with hypogonadism, which causes unnaturally low testosterone.

Doctors were encouraged not to prescribe testosterone drugs for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive experienced by most men as they get older.

Testosterone Therapy Lawsuits

Over the past two years, a growing number of Androgel lawsuit, Testim lawsuits, Axiron lawsuit or other testosterone drug lawsuits have been filed against manufacturers of the various different drugs, alleging that inadequate warnings have been provided about the risk of cardiovascular injuries.

There are currently more than 2,000 product liability lawsuits filed by men throughout the U.S. who have suffered a sudden heart attack, stroke, deep vein thrombosis or death while using the popular low T drugs.

All of the complaints involve similar allegations that drug makers manufactured the disease of “low T” through aggressive marketing, resulting in men using the prescription drugs when they had no real medical need. Plaintiffs claim that if the manufacturers had warned about the risk of testosterone health problems, severe and sometimes fatal injuries may have been avoided.

In the federal court system, the testosterone litigation has been centralized as part of an MDL, or Multidistrict Litigation, for coordinated pretrial proceedings. Cases involving various different types of testosterone drugs, including gels, injections and patches, have been consolidated before one judge given the common questions of fact and law involved in the litigation.

As part of the coordinated pretrial proceedings, a small group of Androgel cases are being prepared for trial first, since that is the most widely used testosterone drug. Known as “bellwether” cases, a series of six trials are scheduled to begin about one-per-month between October 2016 and April 2017, to help gauge how juries may respond to certain evidence and testimony that is likely to be offered throughout the litigation.

While the outcome will not be binding in other cases, the process is designed to help the parties negotiation testosterone injury settlements, which may avoid the need for hundreds of individual trials to be scheduled in courts throughout the U.S.