Testosterone therapy is appropriate for some people, but far more use this hormone than should. We’ve written about the dangers of the misguided use of testosterone (here and here), and with recent research supporting a higher level of scrutiny, the FDA is going to investigate the increased risk of cardiovascular harm associated with testosterone therapy.
Although the feds have been aware of the potential risks, they were spurred into the most recent action after two studies showed that taking testosterone raised the risk of stroke, heart attack and death among men taking testosterone. One study, published in November in the Journal of the American Medical Association (JAMA) was conducted among a population of veterans, and the other, published last month in PLoSOne, concerned older men and younger men with pre-existing heart disease.
As explained in the Los Angeles Times, the more recent research concluded that men older than 65 and younger men with diagnosed heart disease were at least twice as likely to have nonfatal heart attacks in the 90 days after they were prescribed testosterone medication than were men of the same age and health status who did not take the hormone supplement.
Such supplementation did not appear to present the same risk for men younger than 65 with no diagnosis of cardiovascular disease. But that doesn’t mean taking the hormone is a good idea unless you have a condition that’s more thoroughly diagnosed than the widely advertised “low T,” which often represents “disease mongering” more than it does disease.
The former, as we’ve often discussed, is the inflation of symptoms of, for example, normal aging into something that’s wrong and needs to be treated. Many men take testosterone to boost their libido, for example, or to build muscle, but who are otherwise perfectly healthy.
But evidence is building that they’re risking their heart health.
The PLoS One study is the third in four years to signal the potential for substantial risks for many men.
As reported by The Times, prescriptions for testosterone patches, topical gels and creams increased fivefold between 2000 and 2011, and are used by 3 in 100 U.S. men older than 40. An estimated $1.6 billion is spent annually on prescription testosterone supplements, and the fastest-growing market for them is younger men.
The newest study analyzed 55,593 men who received prescriptions for testosterone from 2006 to 2010, and compared the subjects to themselves before and after receiving their first testosterone prescription.
It also compared the men who got prescriptions with a similar group who got a first prescription for an erectile dysfunction medication. These subjects usually are of similar age, health profiles and present similar symptoms, so they are comparable standards of comparison. But because erectile dysfunction drugs (such as Viagra and Cialis) don’t affect hormone balance and work differently from testosterone supplements, the researchers can make conclusions about a drug’s effect, not just draw a correlation between the men taking a drug and a negative outcome.
The PLoS researchers called for larger clinical trials to be conducted to discern which men might incur risks from testosterone supplementation that outweighed its benefits. For people diagnosed with hypogonadism – in men, it’s the diminished function of the testes to produce adequate amounts of testosterone – the benefits of supplementation can outweigh the risks.
Until such additional trials are conducted and analyzed, the researchers wrote, doctors should discuss the potential for “serious cardiovascular events” for patients considering testosterone therapy, “particularly for men with existing cardiovascular disease.”
For its part, the FDA says patients shouldn’t necessarily stop taking their medications, but they should talk to their doctors. And the agency asked both doctors and patients to report adverse effects to its MedWatch program.