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Is the FDA Wrong About Testosterone Heart Risk?

The FDA warns about a testosterone heart risk but a new study says men with low T are at risk of premature death and cardiovascular disease.

aBeware testosterone treatment! That has been the message from the Food and Drug Administration for years. The agency makes it very clear that doctors should not prescribe testosterone for men with low hormone levels unless they have a diagnosed medical condition such as hypogonadism brought on by chemotherapy, infection or some other very serious problem. The FDA warns that the testosterone heart risk is worrisome. It cautions about an “increased risk of heart attacks and strokes in patients taking testosterone.”

But research published in the Annals of Internal Medicine (May 14, 2024) suggests that low testosterone levels are associated with a higher rate of all-cause mortality. Even more alarming, men with very low levels of testosterone are at higher risk of cardiovascular disease.

Low Testosterone Heart Risk? Man Bites Dog!

For years the Food and Drug Administration has been telling doctors and their male patients that testosterone treatment could increase a man’s risk of heart attack, stroke or other cardiovascular calamities. We have heard nary a word from the FDA about the dangers of low testosterone levels.

The idea that low levels of male hormones (androgens) could be dangerous has apparently not made it to the FDA’s radar scope. The latest research will hopefully change that.

A meta-analysis published in the Annals of Internal Medicine reports that low testosterone levels are associated with a shorter lifespan. The investigators reviewed 11 studies involving more than 24,109 men from Australia, Europe and North America. Median ages ranged from 49 to 76 years.

The men with low T (below 213 ng/dL [nanograms per deciliter]) had shorter lifespans. So, what is normal? you are asking. That depends a bit on whom you are asking:

  • Mount Sinai lists normal testosterone levels at 300 to 1,000 ng/dL
  • Medical News Today states that typical adult man ranges from 265 to 923 ng/dL
  • WebMD gets a bit more granular:
    • Normal testosterone in men ages 19-49 = 249 to 836 ng/dL
    • Normal testosterone in men ages 50 and older = 193 to 740 ng/dL

But wait…it gets even more complicated.

An article in the Journal of Urology, Dec. 2022, asks the question:

“What Is a Normal Testosterone Level for Young Men?”

The answer:

  • Men 20-24 years of age: 409 to 558 ng/dL
  • Men 25-29 years of age: 413 to 575 ng/dL
  • Men 30-34 years of age: 359 to 498 ng/dL
  • Men 35-39 years of age: 352 to 478 ng/dL
  • Men 40-44 years of age: 350 to 473 ng/dL

But wait…it gets even more complicated.

The Harvard Medical School Harvard Health Publishing put out an article called “Testosterone, Aging and the Mind.” It contains a table of testosterone levels (ng/dL) in healthy men. The source: “Male Testosterone: What is Normal?” was published in Clinical Endocrinology, March, 2005.

Here are the levels in the Harvard publication:

  • Men 50-59 Total testosterone 252-916
  • Men 60-69            ”                     196-859
  • Men 70-79            ”                      156-815

By now you should be thoroughly confused. The powers that be have been all over the map when it comes to “normal” testosterone levels. Clearly, age has a major impact on what is considered healthy or normal.

The FDA has seemingly ignored the question of whether low testosterone levels contribute to cardiovascular disease, especially in older men.

The low testosterone heart risk revealed in the Annals of Internal Medicine (May 14, 2024) showed up when total testosterone was below 153 ng/dL. Below that level, men had a higher mortality rate from cardiovascular disease. But there was also a signal that when total T levels dropped below 213 ng/dL, men were at risk of dying from any cause.

The Low Testosterone Heart Risk is Not New!

A study in PLoS One (June 28, 2022) showed that men treated for prostate cancer with androgen deprivation therapy (ADT) are at substantially higher risk of heart disease. That is an inconvenient truth.

The authors conclude:

“ADT was associated with an increased risk of CVD among prostate cancer patients.”

Men with prostate cancer are caught in a bind. On the one hand, they are doing their best to control the cancer. On the other hand, the low testosterone levels resulting from treatment can increase the risk of cardiovascular disease, osteoporosis and bone fractures (PLoS One, Jan. 4, 2023). Other complications of androgen deprivation therapy (ADT) or low T include sexual dysfunction, weight gain and depression.

Low Libido, Low Testosterone and Testosterone Treatment:

Q. My wife was complaining about my low libido, not to mention general grumpiness. The doctor diagnosed depression, but I vehemently disagreed and demanded he check my testosterone levels. They were around pre-teen levels.

He put me on a topical gel that helped somewhat. However, I found the results inconsistent (as measured by blood tests and also by my mood and libido).

Since my primary doc wasn’t listening to me and wasn’t a specialist, I found a clinic. They switched me to shots and worked with me to get my levels consistent. It turns out I feel best at the higher end of the normal range. My moods leveled out. I had tons more patience. That competitive drive reignited. I can think more clearly; it’s like my mind is sharper. My libido is back too.

I get regular blood tests to make sure my testosterone level is constant and that I don’t get side effects.

A. Thank you for sharing your story. The Food and Drug Administration discourages the use of testosterone in older men, “even if a man’s symptoms seem related to low testosterone.” The agency warns that such hormone replacement could increase the risk for heart attacks and strokes.

Despite that caution, a review of 13 randomized controlled trials found that testosterone increased muscle strength without elevating the risk for heart problems or prostate cancer (Gerontology, July 26, 2023). A larger study also concluded that such treatment did not increase cardiovascular events (Lancet. Healthy Longevity, June 2022).

As long as you are under medical supervision and get regular follow-up, your regimen seems helpful.

A man wants to know if he should worry:

“My endocrinologist put me on testosterone because my hormone levels were very low. When I moved two years ago, my new doctor said I shouldn’t take it.

“I recently moved again and got a new doctor. He ran a full workup on me before putting me back on testosterone. My testosterone was again very low, and I suffered from fatigue. My PSA was good so there was no worry about prostate cancer. My blood work showed no signs of liver or kidney damage. In addition, my EKG and echocardiogram were normal, suggesting my heart is in good shape.

“I feel so much better on testosterone. Should I be worried about continuing on this hormone?”

The Food and Drug Administration frowns upon doctors prescribing testosterone to men with low levels of this hormone due to aging.

FDA’s Position on Proper Testosterone Prescribing:

The Food and Drug administration makes it clear that the only conditions for which testosterone is appropriate are:

“• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.

• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.”

Those are all very serious medical conditions. What is not included is low testosterone levels due to aging or anything else for that matter.

Don’t Prescribe Testosterone Unless…

Here is the FDA’s message about Low T prescribing:

“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.”

Research Exonerates Testosterone Heart Risk!

Well before the most recent research was published, scientists presented their analysis of testosterone and cardiovascular complications The Lancet. Healthy Longevity (June, 2022). The investigators analyzed data from 35 clinical trials involving more than 3,400 men. In particular, they were looking for a testosterone heart risk as well as other cardiovascular problems such as strokes.

Here is what they discovered:

“We have conducted the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism. Testosterone treatment did not increase cardiovascular event risk in the short term to medium term. Furthermore, we did not identify subgroups with high cardiovascular risk.”

The bottom line seems to be that men with low levels of testosterone who received extra T did not have more heart attacks, strokes or deaths compared to those on placebo.

The conclusion:

“An ongoing trial (NCT03518034) is investigating the longer-term safety of testosterone, and future studies are needed to analyse the risk–benefit and cost-effectiveness of testosterone therapy. However, the current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism.”

The authors offer this advice to their medical colleagues:

“Implications of all the available evidence 

“Men with hypogonadism should be counselled that there is no current evidence that testosterone treatment increases cardiovascular risk in the short to medium term.”

The FDA Is Not Likely to Reverse Course:

According to the agency, doctors should be wary of a testosterone heart risk:

“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy.”

The FDA makes it very clear that it does not approve of doctors prescribing testosterone therapy to men with low hormone levels due to aging:

“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.”

Testosterone Treatment for Low T:

Television advertisements have promoted this male hormone as a way to counteract loss of libido and muscle strength. The marketers have dubbed such symptoms coupled with low testosterone “low T.” But some experts have raised safety questions, and the FDA has put a warning on this drug.

Prior Studies on the Testosterone Heart Risk:

Several studies have given conflicting answers to the safety question. That may not be too surprising, given that an epidemiological analysis determined that a placebo-controlled trial of the testosterone heart risk would need to recruit at least 17,664 men to each arm of the study (Onasanya et al, The Lancet. Diabetes & Endocrinology, Nov. 2016).

A prior meta-analysis was conducted on 30 randomized controlled trials to determine the testosterone heart risk. All together, the studies included 5,451 men. In addition to heart attack, stroke and death, the investigators analyzed the data to see if there were links to heart failure, arrhythmia or hospitalization for cardiac procedures.

They bemoaned the poor quality of the data, but concluded,

“We did not find any significant association between exogenous testosterone treatment and myocardial infarction, stroke, or mortality in randomized controlled trials.”

Alexander et al, American Journal of Medicine, March 2017

The old meta-analysis combined with the new meta-analysis gives us some reassurance that T treatment does not pose an obvious testosterone heart risk. For men with low libido and other symptoms of hypogonadism it may be worth a conversation with a physician who is familiar with hormone therapy.

Does Low Testosterone Increase the Risk of Heart and Cardiovascular Complications?

So the evidence does not seem to suggest that supplying extra testosterone to men with low levels of this hormone will increase the risk of heart attacks, strokes or early death from cardiovascular causes. But what about the effect of low testosterone on heart health? That is not something the FDA likes to discuss.

Doctors induce low testosterone levels in men with prostate cancer. It is called androgen deprivation therapy (ADT). We have a lot of data about the impact of low T on the cardiovascular system. Here is just the most recent overview (PLoS One, June 28, 2022).

Here is how the researchers introduce their study:

“Although ADT is beneficial in providing better overall survival, a longer ADT treatment duration will lead to increased complications. The most commonly reported adverse events related to ADT were associated with androgen loss, including decreased libido, gynecomastia [breast growth], weight gain, cognitive deficiency, overactive bladder, metabolic disorders (hyperglycemia, hyperlipidemia, cardiovascular events), and skeletal related events [osteoporosis, fractures]. Amongst these cardiovascular events were the major targets in subgroup studies due to their life-threatening nature and consequences. Surgical castration involving an orchiectomy increased the risk of cardiovascular events even higher than did other medical castration medications, as seen in database studies.”

OK, that’s pretty technical, but the bottom line is that inducing low testosterone levels has some pretty serious health consequences. Here is the bottom line from these investigators:

Conclusions:

“ADT is associated with an increased risk of CVD. For long-term prostate cancer castration therapy, doctors should be aware of this complication and arrange for proper management.”

The authors of the new research point out that:

“Alternatively, several randomized control trials have shown that a supplement of testosterone can improve metabolic profiles and possibly decrease the risk of CV morbidity.”

What We Do and DO NOT Know about the Testosterone Heart Risk:

Here is our overview of the testosterone heart risk controversy. 1) There are not clear indications that testosterone treatment increases the risk of heart attacks, strokes or death from cardiovascular disease. 2) Lowering testosterone levels with prostate cancer medications or surgical castration does increase the risk of cardiovascular disease (CVD).

We now know that naturally low testosterone levels are also associated with an increased risk of CVD thanks to the research published in the Annals of Internal Medicine (May 14, 2024).

It confirms the research published in Frontiers in Cardiovascular Medicine (April 14, 2022) that notes:

“In recent years, some studies have indicated that low testosterone levels might increase the risk of coronary artery disease, death from congestive heart failure, and all-cause mortality.”

What is your experience with testosterone? Please share your story in the comment section below.

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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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Citations
  • Hudson, J., et al, "Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis," Lancet Healthy Longevity, June, 2022, doi: 10.1016/S2666-7568(22)00096-4
  • Yeap, B.B., et al, "Associations of Testosterone and Related Hormones With All-Cause and Cardiovascular Mortality and Incident Cardiovascular Disease in Men : Individual Participant Data Meta-analyses," Annals of Internal Medicine, May 14, 2024, doi: 10.7326/M23-2781
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