More Studies Needed on Testosterone Cardiovascular Risks: Report

Amid increasing concerns over the link between side effects of testosterone drugs and heart attacks, a number of experts are calling for additional research to properly evaluate the potential cardiovascular risks associated with popular drugs like AndroGel, Axiron, Testim and others. 

In an editorial report published this month in the medical journal The Lancet Diabetes & Endocrinology, Professor Stephanie Page indicates that larger and more comprehensive clinical trials need to be conducted to evaluate the testosterone cardiovascular risks among older men.

Dr. Page, from the University of Washington and Harborview Medical Center in Seattle, raised concerns about recent studies that suggest men may face an increased risk of heart attacks, strokes and death from testosterone replacement therapy, calling for sufficient funding to be made available to ensure that the rapidly growing low testosterone drug industry does not lead American men into a health crisis.

She said that recent studies “should galvanise both the public and medical communities to fund an appropriate clinical study to assess the risks and benefits of testosterone treatment in older men in an era when millions of men are using testosterone every day.”

The commentary comes as the FDA and European health regulators are examining the cardiovascular safety of testosterone drugs, and a growing number of AndroGel lawsuits, AndroDerm lawsuits, Testim lawsuits, Axiron lawsuits and cases involving other testosterone products are being filed in courts throughout the United States.

In November 2013, a study published in the Journal of the American Medical Association evaluated the effects of low testosterone among 8,700 veterans who underwent a coronary angiography. Researchers found that older men who received testosterone drugs faced a 29% higher risk of heart attacks, strokes or death when compared to men with low testosterone levels who did not use the medications.

That study was followed by a larger study published in the medical journal PLoS One in January 2014, which evaluated data on more than 55,000 men who received an initial testosterone prescription and compared them to men who received a first prescription for an erectile dysfunction drug. Researchers found that during the first 90 days using the drugs, low testosterone drugs doubled the risk of heart attack for younger men with pre-existing heart disease and for older men, regardless of any prior heart issues.

Dr. Page pointed out limitations in both studies, which were not randomized, controlled clinical trials specifically designed to evaluate the cardiovascular risks of testosterone treatments. She also pointed out that there have been contradictory findings in published studies, highlighting the need for a larger, more comprehensive analysis.

“Although data from recent studies suggest testosterone negatively affects cardiovascular risk in older men, these studies have important limitations,” Page notes. “Together, the contradictory findings in these studies draw attention to the inherent shortcomings of such retrospective analyses in providing definitive data for clinical decision-making about testosterone treatment.”

Sales of testosterone replacement drugs generate more than $2 billion a year for the pharmaceutical industry, largely fueled by direct-to-consumer advertisements that many critics indicate has caused widespread overuse of the medications among men with no real medical need.

According to allegations raised in testosterone drug lawsuits being filed by men throughout the United States, drug makers have placed their desire for profits before consumer safety by neglecting to fund adequate studies to evaluate the cardiovascular risks associated with their medications.

In February 2014, the Endocrine Society also called for large-scale scientific studies to help doctors better understand the potential risk of heart attacks and other cardiovascular injuries that may be caused by testosterone treatments. The Society indicated that until evidence of the heart safety is confirmed, patients should be made aware of the potential risk of cardiovascular events and urged doctors to follow clinical practice guidelines to ensure appropriate prescribing of testosterone.