COMMENTARY

Patients Should Be Warned of Testosterone Risks

Gerald Chodak, MD

Disclosures

October 07, 2014

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Hello. I am Dr Gerald Chodak for Medscape. This week, I want to talk about testosterone replacement therapy. This is prompted by a recent US Food and Drug Administration (FDA) review panel that voted overwhelmingly to conduct further analysis into the safety of testosterone replacement.

Throughout the United States, abundant advertisements promote testosterone replacement for men with decreased energy and low sex drive. Yet that was not the primary indication testosterone was approved for, which was for men with low testosterone secondary to certain illnesses that affect testosterone levels.

What is prompting this panel recommendation? Two uncontrolled trials[1,2] have suggested that men who are taking or starting testosterone have an increased risk for cardiovascular death, stroke, and heart attack. One study[1] found that men under age 65 who have a history of coronary artery disease have an increased risk, and men over age 65 have an increased risk even if they do not have underlying cardiovascular disease. The second study found that men had an increased risk for strokes or heart attacks within 90 days of starting testosterone replacement.[2]

The advertisements are abundant, as I said, but there is little evidence to show that men with low testosterone secondary to aging are really benefiting—and in fact, a number of prospective, randomized trials are in progress to evaluate exactly those indications. These studies are trying to determine to what extent men's quality of life will be affected by increasing a low testosterone level with replacement therapy.

One of the problems with the advertisements is that they are marketing testosterone replacement to men who may not have low testosterone levels. In 2013, one study found that about one quarter of the prescriptions were given to men who never had their testosterone levels measured.[3] Thus, the idea of trying to reset the clock, improve men's overall function, their ability to exercise, and their sexual function has been a marketing ploy that is not based on good evidence or support.

The bottom line for now is that men who are considering going on testosterone replacement should be made aware of the known side effects and the unknown side effects. The long-term safety of these drugs is not well determined, particularly in men who may have any underlying cardiovascular disease. As the studies are completed, we hope to have a better idea of what to tell men. The idea that marketing should continue to promote testosterone replacement in men for whom it is not clearly indicated is something that should be stopped. Hopefully, the FDA will proceed to limit its use unless men clearly have the right indication.

I look forward to your comments. Thank you.

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