Is it safe for older men to take testosterone drugs even if they are not diagnosed with hypogonadism?
According to many studies, it may not be, but that hasn’t stopped new clinics from distributing the medications to men who want them for lifestyle reasons.
FDA Concerned About Potential Testosterone-Heart Attack Link
In January 2014, the FDA released a safety communication announcing they were investigating a potential connection between testosterone-replacement drugs and an increased risk for stroke, heart attack, and death. They based their decision to investigate on two separate studies that suggested such a risk in men prescribed testosterone therapy.
The first was published in the Journal of the American Medical Association (JAMA) in November 2013, and showed that men receiving the therapy had about a 30 percent increased risk of cardiovascular problems over men who were not taking the drugs.
The second study was published in PLoS One, and reported that testosterone therapy increased risk of heart attack in older men, as well as in younger men who had already been diagnosed with heart disease. Men 65 years and older experienced a two-fold increased risk of heart attack within the first 90 days of taking testosterone. Younger men with a history of heart disease experienced a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription.
In September 2014, the FDA convened an expert panel to further investigate the issue. The panel recommended that the FDA restrict the use of the drugs, and require labels on them with language clearly stating their intended use—which should be only for men diagnosed with hypogonadism (low testosterone caused by a medical condition).
Men Taking Testosterone for Lifestyle Reasons
Those who run the new testosterone clinics, however, aren’t following the FDA’s advice. According to a report by Fusion Media and other media outlets, new specialized clinics are popping up across the nation, particularly in the southern states, that offer testosterone replacement drugs to men for lifestyle reasons.
One of the complaints that appears again and again in testosterone replacement injury lawsuits is that the manufacturers purposely advertised the drugs for symptoms like fatigue, muscle loss, and reduced libido—all of which can be typical signs of aging, or symptoms of other issues that aren’t hormone-related.
The FDA approved the use of these drugs only for men diagnosed with low testosterone because of a medical condition, but as noted in the Wall Street Journal, doctors prescribed a lot of the medications for off-label purposes. An FDA analysis found that only about half of men taking testosterone therapy had been diagnosed with low testosterone, and a quarter had no evidence of even having been tested prior to taking the drugs.
The administration was particularly concerned about this last fact, since without a diagnosis, doctors can’t determine how much testosterone men need to bring them up to normal levels, which can result in men taking too much.
Those taking the drug report that it helps them to feel younger, stronger, and more energetic. The hormones have become so popular that chains of shops have opened all over the country, run by entrepreneurial doctors interested in promoting well being.
Many men remain unaware of the dangers, however, which is why a number of patients have filed lawsuits against manufacturers like AbbVie and Eli Lilly.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
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