The People's Perspective on Medicine

FDA Issues Testosterone Warning, But Research Is Murky

The FDA warns men not to take testosterone except in very limited circumstances, although some research suggests testosterone benefits heart health.

Television commercials focusing on the dangers of “low T” have gotten many men to ask their doctors for a prescription. In 2013, prescription testosterone medicines such as AndroGel or Axiron hit $2 billion in sales.

But the Food and Drug Administration is nervous about this trend. The agency is warning doctors to limit prescribing testosterone only to men who have low testosterone levels stemming from medical conditions and confirmed by lab tests.

Here is the FDA’s safety announcement (March 3, 2015):

The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.

Are the FDA’s Concerns Justified?

Testosterone and Increased Risk

A year ago an article was published in the journal PLOS One (Jan. 29, 2014) titled “Increased Risk of Non-Fatal Myocardial Infarction [heart attacks] Following Testosterone Therapy Prescription in Men.” The authors concluded that testosterone supplementation was associated with an increased risk of adverse cardiovascular-related events.

A study from the VA had also found that men undergoing coronary angiography (a way of looking at the health of coronary arteries) were more likely to have a heart attack or stroke or to die if they were taking testosterone (JAMA, Nov. 6, 2013).

Testosterone Doesn’t Increase Heart Risk

What is so fascinating about the FDA’s recent warning, though, is that it contradicts a couple of recent research analyses. Urologist Abraham Morgentaler reviewed the medical literature and concluded that there was no increased heart risk for men taking additional testosterone (Mayo Clinic Proceedings, Feb. 2015). Dr. Morgantaler concluded:

“The largest meta-analysis to date revealed no increase in CV risks in men who received T [testosterone] and reduced CV [cardiovascular risk] risk among those with metabolic disease. In summary, there is no convincing evidence of increased CV risks with T therapy. On the contrary, there appears to be a strong beneficial relationship between normal T and CV health that has not yet been widely appreciated.”

A different study looked at men’s natural testosterone levels and their risk of cardiovascular events as well as death from any cause (Journal of Clinical Endocrinology and Metabolism, online Jan. 13, 2015). This longitudinal community based study concluded that testosterone levels in themselves, either high or low, are not to blame for cardiovascular problems but are instead “a marker for other cardiovascular risk factors.”

Another careful analysis of 75 trials concluded that there’s no evidence of a causal role between testosterone supplementation and cardiovascular events (Expert Opinion on Drug Safety, Oct., 2013).

What to Make of Confusing and Contradictory Results?

It is hardly any wonder that consumers are confused. The FDA says testosterone boosts the likelihood of having a heart attack or a stroke. Dr. Morgentaler says that his analysis of the available research suggests that testosterone is actually good for cardiovascular health. There are many other researchers who agree with him.

Clearly, the question of testosterone safety is unresolved. Until there is a definitive answer to this problem, men and their physicians should feel comfortable in using testosterone when it is needed; it should not, however, be regarded as a panacea to make men feel younger, stronger, slimmer and sexier.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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