FDA to Review Risk of Testosterone Heart Attack, Stroke

Los Angeles, CAThere is little doubt that “Low-T” has ascended to dizzying heights in the lexicon of men’s health, and pop culture surrounding men’s health, in the last decade. “Low-T” is the requisite slang for low testosterone, and there is little doubt that the latter is a real and debilitating problem with some aging men. Doctors will tell you that testosterone replacement therapy, designed to shore up levels of testosterone that naturally diminish as men age, has its place for some patients. But the “Low-T” phenomenon has spurred a plethora of interest in products that boost testosterone levels in men who pursue the treatment more out of vanity, than medical need. And there are testosterone side effects, as one recent study points out.

Los Angeles-based William Finkle, an epidemiologist and CEO of the firm Consolidated Research, recently teamed up with researchers from UCLA and the National Institutes of Health to study the impact of testosterone therapy on the cardiovascular system. The concern is testosterone heart attack.

Anna Maria Tremonti, a broadcast journalist with the Canadian Broadcasting Corporation (CBC) in Toronto, queried Finkle on his findings with regard to testosterone side effects.

“We found two things,” Finkle told Tremonti in an interview carried February 10 on The Current, a weekday news journal that airs on the CBC’s national radio service. “In men over 65, the increase in the rate of heart attack doubled shortly after initiating therapy…the second thing that we found, was that in younger men, those under 65, with a history of heart disease, the risk of heart attack also doubled shortly after initiating therapy.”

There is also a risk for testosterone stroke, given that the viscosity of blood with testosterone therapy was found to increase or thicken. The CBC reports that the US Food and Drug Administration (FDA), based on this recent finding, announced it would be looking more deeply into the safety and efficacy of testosterone therapy and approved products.

While the issue over testosterone side effects has suddenly gained traction in the national consciousness (and has now caught the attention of the FDA), it’s hardly a new issue. In fact, Finkle told the CBC that a study and accompanying editorial published July 8, 2010 in the New England Journal of Medicine (NEJM) prompted Finkle and his associates to action.

“A clinical trial of testosterone was discontinued by the ethics committee due to excess cardiovascular adverse events in those taking testosterone.” Finkle noted that the accompanying editorial urged caution with regard to testosterone use, together with the need for further studies, “and that is what initiated our thinking that a study was worthwhile,” Finkle said.

The FDA was silent on the issue in 2010, but is sitting up and taking notice now.

Pundits say the agency needs to, given the swelling popularity of testosterone supplementation by men. Prescriptions have quadrupled in the US from 2001 through 2011. In 2013, sales of approved testosterone supplements outpaced sales of Viagra.

“We don’t know very much about this therapy,” said Dr. Steve Nissen, the noted cardiologist at the Cleveland Clinic who famously blew the whistle on Avandia several years ago.

“Once it appears on television, with seductive ads that make men think it’s a fountain of youth, you’re going to see a lot of off-label usage,” Nissen said.

Finkle et al looked at data culled from a massive national database, and examined data collected from 55,593 men who were prescribed testosterone. “The biology of testosterone is that testosterone increases hemoglobin (red blood cells),” Finkle told the CBC’s Tremonti. “The increase in red blood cells can coagulate, and cause an increase in viscosity, or thickening in the blood. An increase in viscosity of the blood means thicker blood,” Finkle says. “If the blood is thicker, then that increases the risk of clotting, and hence the risk of blockage and so forth. There’s a lot more to it, but that would be a way of understanding [that] red blood cells leads to thickening, which leads to clotting.

“In addition to that, testosterone increases estrogen production, and estrogens are known in [numerous] epidemiologic studies and very well-controlled randomized clinical trials, in both women and in men, to increase the risk of heart attack shortly after initiation of use. With the increase in red blood cells, and the coagulation - and the increase in estrogen it’s biologically plausible that a sudden increase [in cardiovascular risk] can occur. Whether it would be twofold is unknown [but] that’s what we found in these data.”

Finkle holds that testosterone supplementation increases muscle and that can be a benefit to certain patients, in that preserving muscle could help avoid falls in older men - falls that could result in serious consequences to their health. But Finkle also acknowledges that in men for whom testosterone is not a real health issue, they are motivated to a greater degree from advertising and not necessarily from need.

CBSnews.com reported recently on a study that suggested 43 percent of men receiving testosterone already presented with normal levels of natural testosterone.

For anyone thinking of a testosterone lawsuit, there are no cautions with regard to risk for testosterone heart attack or testosterone stroke on product labeling - although this could change given the FDA’s recently announced review of the safety of currently approved testosterone supplementation, including gels.

“I expect [the FDA] will examine the cardiovascular risk along with the benefits of testosterone,” Finkle concluded. “I’m not sure what the policy options are, but one would be to modify the warnings associated with the use of testosterone such as Andro Gel.”

For an individual to succumb to cardiac arrest due to the thickening of blood fostered from the use of testosterone, a family might well initiate litigation alleging testosterone death.