Medical Studies Show An Increased Risk Of Cardiovascular Events In Older Men Prescribed Testosterone Medications Such As Axiron, AndroGel, And Testim
FDA MedWatch Alert issued on January 31, 2014
Drug Injury Watch article posted January 31, 2014
Testosterone replacement therapy (TRT) is also referred to as androgen replacement therapy (ART) and male hormone replacement therapy.
Older men who used testosterone gel, patch, or injection products for a medical condition called hypogonadism or for other reasons are more likely to have a serious cardiovascular event, some of which have been fatal, according to some medical research.
Unfortunately, while it is estimated that the number of middle-aged men in the U.S. getting testosterone treatment has more than tripled over the last decade, the long-term risks are largely unknown.
Some of the prescription testosterone drug products approved by the FDA and available for use to treat low testosterone, or "Low T" syndrome, include:
Men with certain cardiac conditions such as heart disease who are prescribed these testosterone replacement therapy medications face an increased risk of cardiovascular adverse events according to a medical study article, "Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels", published in the November 6, 2013 edition of the Journal of American Medical Association.
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To put this rather alerting drug safety information about testosterone replacement therapy into context we look to a November 2013 medical news report, "'Low T' Tx Tied to Higher Stroke Risk in Veterans":
Steven Nissen, MD, of the Cleveland Clinic, characterized the study results as a red flag that demands "attention not just from physicians but also from regulators."
Nissen, who was not involved the study, noted that he is among of group of physicians who "have been worried about testosterone replacement therapy, which is increasingly commonly prescribed and largely fueled by direct-to-consumer advertising that's urging men to get tested for low testosterone and then to seek replacement."
The risk with that approach, he said, is that clinicians feel compelled to treat a biochemical problem -- low levels of testosterone -- and that treatment could trigger a "clinical problem that's far more grave, which is coronary heart disease." [emphasis added]
An earlier clinical trial entitled Testosterone in Older Men with Mobility Limitations (TOM) also associated testosterone drugs like Axiron, AndroGel, and Testim with a higher rate of cardiovascular events, as covered in this July 2010 article, "Increased CV Events Halts Testosterone Trial in Older Men":
Testosterone treatment in men aged 65 years and older who have limitations in mobility is associated with an increased risk for cardiovascular events, including myocardial infarction and hypertension, according to a study published online June 30 in the New England Journal of Medicine.
Because of these events, the treatment phase of the trial, which was supported by the National Institute on Aging of the National Institutes of Health, has been stopped....
The men in the trial were an average of 74 years old and had high rates of chronic diseases such as diabetes and cardiovascular disease....
The cardiovascular-related events included myocardial infarction, arrhythmias, hypertension, and 1 death from a suspected myocardial infarction.
You can read more about this TOM trial discontinued in 2009 and the drug-safety issues that were found during it in this July 2010 New England Journal of Medicine article, "Adverse Events Associated with Testosterone Administration".
We will continue to report about testosterone therapy and its increased risk of death, heart attacks, and strokes -- as well as how these "Low T" drugs like Axiron, AndroGel, and Testim became so popular -- in our next article about this emerging drug safety issue.