FDA Testosterone Reversal: Were Men Misled for a Decade?

For more than a decade, federal regulators frightened doctors and patients about testosterone. They warned that this hormone might trigger heart attacks and strokes, fuel prostate cancer and worsen an enlarged prostate. Now an extraordinary FDA Testosterone Reversal is dismantling many of those cautions. Were millions of men and their physicians misled by warnings that went far beyond the available evidence?

Here Is the Old FDA Message

“FDA Drug Safety Communication:

FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use”

“FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy.”

Here Is the FDA Testosterone Reversal

On June 18, 2026, the Department of Health and Human Services announced that the Food and Drug Administration is requesting major changes to the prescribing information for testosterone replacement products.

The proposed revisions would:

• Remove the statement that the safety and effectiveness of testosterone have not been established for men with age-related low testosterone.
• Dramatically narrow restrictions involving prostate cancer.
• Soften warnings that testosterone may worsen symptoms of an enlarged prostate.

This comes after the FDA removed its prominent cardiovascular warning in 2025. Add it all together and the agency’s old testosterone warnings are being dismantled piece by piece.

The FDA’s Old Warning Scared Doctors!

For many years the FDA’s warnings about testosterone treatment changed medical practice. Many physicians became reluctant to prescribe testosterone even when men had repeatedly low hormone levels and symptoms such as diminished libido, fatigue, depression, loss of muscle or reduced bone strength.

Here’s how the FDA made prescribing testosterone seem scary:

“Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

In other words, men had to be suffering from serious “medical conditions” such as: orchiectomy (castration), chemotherapy-induced testicular damage, congenital gonadotropin deficiency, Klinefelter syndrome or some other very serious health problem.

The FDA demanded healthcare professionals caution patients about a testosterone heart risk:

“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy.”

Patients were understandably frightened. Who would want to relieve fatigue or restore sexual interest if the price might be a heart attack or stroke?

In addition, the agency classified testosterone as a controlled substance, CIII. Prescribers had to keep a DEA registration current and testosterone had to be kept under a double-lock system similar to that required for ketamine or codeine.

The FDA’s Changing Course

HHS says the proposed labeling revisions reflect a “comprehensive review of new clinical data and existing scientific evidence.” According to the department, the evidence that has accumulated since 2015 no longer justifies the sweeping restrictions.

That raises an uncomfortable question: Why did it take the FDA so long to acknowledge that its original warning may have been misguided?

The FDA Testosterone Reversal Started with Heart Risk

The most important evidence came from a large clinical trial known as TRAVERSE. It was published in the (New England Journal of Medicine, July 13, 2023).

The investigators recruited 5,246 men between 45 and 80 years old. The participants had symptoms of low testosterone, two fasting testosterone measurements below 300 ng/dL and either established cardiovascular disease or a high risk for it.

These were precisely the men who might have been expected to experience cardiovascular complications if testosterone were dangerous for the heart.

Participants were randomly assigned to use either testosterone gel or a placebo gel. The researchers tracked heart attacks, strokes and deaths from cardiovascular causes.

Their conclusion was:

“Testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events.”

Let me be perfectly clear. I hate it when scientists use the word “noninferior.” It makes an important result nearly incomprehensible to ordinary people.

In plain English, men receiving testosterone were no more likely to suffer a heart attack, stroke or cardiovascular death than men receiving placebo.

The primary cardiovascular endpoint occurred in 7 percent of the men receiving testosterone and 7.3 percent of those receiving placebo. That is not evidence of a meaningful increase in cardiovascular danger.

The TRAVERSE trial did report higher rates of certain complications in the testosterone group, including atrial fibrillation, acute kidney injury and pulmonary embolism. Those findings should not be swept under the rug.

Nevertheless, the major cardiovascular catastrophe the FDA had warned about did not materialize. The findings of the TRAVERSE trial were bolstered by the results of other studies (Andrology, January 2026).

Barriers to Prescribing Testosterone

A physician expresses his outrage:

Q. I have practiced medicine for decades. I learned long ago that many men begin to experience lower testosterone levels in their thirties and forties. Some older men end up with very low levels of this hormone.

I have found that testosterone replacement therapy can help these guys maintain both bone and muscle strength. I believe the best benefit is mental clarity and warding off depression. I am glad that the FDA has eased off its cardiovascular warnings, which had no scientific basis.

I think it is absurd, though, that doctors are required to have a DEA license to prescribe testosterone. That’s because it is considered a “controlled” substance.

A. The FDA has indeed withdrawn its boxed warning about heart attacks and strokes from testosterone products. As you note, this hormone is still classified as a “Schedule III” controlled substance. That means the DEA believes it has a modest potential to create physical or psychological dependence.

Why Did the FDA Wait So Long?

The TRAVERSE results were published in June 2023 online and appeared in the July 13, 2023, issue of the New England Journal of Medicine. The FDA did not remove the boxed cardiovascular warning until February 28, 2025.

Even that action was only a partial retreat. The agency continued to discourage testosterone prescribing for men whose low levels appeared related to aging. It also required manufacturers to add or strengthen warnings about increased blood pressure.

How much does testosterone raise blood pressure? In the TRAVERSE trial, the average increase in systolic blood pressure after six months was only 0.3 mm Hg in the testosterone group. Some individual testosterone products may have produced larger increases in ambulatory blood pressure studies, which explains the FDA’s product-specific labeling changes. For many men, climbing a flight of stairs will raise their BP more than 0.3 mm of mercury.

Blood pressure should certainly be monitored. But a possible increase in blood pressure is not the same as a boxed warning about heart attacks and strokes.

Now, more than a year after removing the cardiovascular warning, the FDA says its limitation on testosterone treatment for age-related hypogonadism is also no longer warranted.

The agency appears to be acknowledging what many specialists have argued for years: declining testosterone associated with age should not automatically disqualify a symptomatic man from treatment.

FDA Testosterone Reversal and Age-Related Low T

Testosterone levels often decline as men grow older. That does not mean every tired or grumpy older man needs a prescription.

Diagnosing testosterone deficiency requires more than one low laboratory result. Testosterone levels fluctuate during the day. They are generally highest in the morning and may be temporarily lowered by illness, poor sleep, obesity, certain medications or severe stress.

The American Urological Association considers a total testosterone level below 300 ng/dL a reasonable cutoff supporting the diagnosis of testosterone deficiency. The diagnosis should also include relevant symptoms and normally requires two separate early-morning measurements.

Symptoms of low testosterone may include:

• Reduced sexual desire
• Fewer spontaneous erections
• Erectile difficulties
• Loss of muscle mass or strength
• Fatigue
• Depressed mood or irritability
• Difficulty concentrating
• Reduced bone density
• Unexplained anemia

Many of those symptoms are nonspecific. Sleep apnea, thyroid disorders, diabetes, obesity, depression, chronic illness and medication side effects can all cause similar problems.

That is why a testosterone prescription should not be based on a television advertisement, an online influencer or a man’s desire to feel 25 again.

On the other hand, genuinely low testosterone should not be dismissed merely because a man is getting older.

Low Testosterone and 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. Will the latest research change the agency’s attitude? Probably not.

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

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 [cardiovascular disease] 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.

The FDA Testosterone Reversal and Prostate Cancer

Perhaps the most surprising part of the new government announcement involves prostate cancer. For decades, doctors were taught that testosterone feeds prostate cancer. That belief is not entirely wrong.

Advanced prostate cancer is commonly treated by dramatically lowering testosterone. This is known as androgen deprivation therapy, or ADT. Doctors may prescribe drugs such as abiraterone, leuprolide, degarelix or relugolix to suppress testosterone. In some cases, the testes are surgically removed.

Reducing testosterone can slow the progression of advanced prostate cancer and extend life. But medicine made a leap from that observation to a much broader assumption: If lowering testosterone treats prostate cancer, then giving testosterone must cause prostate cancer.

That conclusion has not held up well. Current testosterone labels have generally warned that the hormone should not be used in men with known or suspected prostate cancer. They have also cautioned that testosterone treatment may increase the risk of developing the disease.

Under the requested revisions, testosterone would be contraindicated only in men with metastatic prostate cancer. That is a huge change. It means the broad prohibition involving known or suspected prostate cancer could be replaced by a far narrower restriction focused on cancer that has spread beyond the prostate.

Does Testosterone Cause Prostate Cancer?

Available clinical trials and epidemiologic studies have not generally demonstrated an increased risk of prostate cancer among men receiving testosterone replacement.

The TRAVERSE investigators also examined prostate safety.

An analysis of the “Long Term Cardiovascular Safety of Testosterone Therapy: A Review of the TRAVERSE Study” in the World Journal of Men’s Health (Aug. 2, 2024) concluded:

“Testosterone therapy was associated with low and similar incidences of high grade or any prostate cancer, acute urinary retention, and invasive surgical procedures for benign prostatic hyperplasia (BPH) compared with a placebo.

“…the TRAVERSE data on prostate safety are very reassuring that treating appropriately diagnosed hypogonadism with TRT [testosterone replacement therapy ] is not associated with increased risk of prostate cancer or BPH exacerbation and that such men might actually benefit from being under routine medical care of urologists and primary care physicians with greater opportunity to discuss male-related health care issues.”

That does indeed sound reassuring, but there is an important catch.

The TRAVERSE trial excluded men with:

• A history of prostate cancer
• A prostate-specific antigen, or PSA, level above 3 ng/mL
• A suspicious prostate examination
• Severe lower urinary tract symptoms
• Other findings suggesting a high risk for prostate cancer

The study therefore does not prove that testosterone is safe for every man with prostate disease.

Prostate cancer can also take years to develop. Even a large randomized trial may not last long enough to detect every long-term effect.

HHS explicitly acknowledges this uncertainty. The proposed labeling continues to recommend that healthcare professionals assess prostate cancer risk, screen men before treatment and monitor them during therapy.

That’s sensible. Removing an exaggerated warning should not mean abandoning appropriate surveillance.

What About Men Who Have Been Treated for Prostate Cancer?

The proposed labeling change could have profound implications for prostate cancer survivors.

Many men who have been successfully treated for localized disease develop symptoms of severe testosterone deficiency. Historically, doctors have often refused to consider replacement therapy because of the fear that any additional testosterone might reactivate the cancer.

Some urologists have become more flexible, especially when:

• The original cancer was localized and considered low risk.
• Treatment appears to have been successful.
• PSA levels have remained low or undetectable for an extended period.
• The man has significant symptoms and repeatedly low testosterone.
• Treatment is coordinated with a urologist or oncologist.
• PSA and testosterone levels are monitored carefully.

The proposed FDA language does not declare testosterone appropriate for prostate cancer survivors. Nor does it establish that treatment is risk-free.

It does suggest, however, that an automatic lifetime prohibition may no longer reflect the best available evidence. That conversation must be individualized. A man with metastatic or actively progressing prostate cancer is in a very different situation from someone treated successfully for a small localized tumor many years earlier.

The Brutal Tradeoff of Testosterone Suppression

Lowering testosterone can be lifesaving for men with aggressive prostate cancer. But androgen deprivation therapy is not benign.

Very low testosterone can contribute to:

• Loss of libido and erectile function
• Hot flashes
• Fatigue
• Muscle wasting and weakness
• Weight gain
• Insulin resistance
• Loss of bone density
• Osteoporosis and fractures
• Depression
• Cognitive difficulties
• Cardiovascular complications

The FDA Testosterone Reversal Does Not Make Therapy Risk-Free

The old FDA warnings may have overstated some dangers, but testosterone is not a harmless wellness tonic.

Possible complications include:

• Increased hematocrit and overly concentrated blood
• Higher blood pressure
• Acne or oily skin
• Breast tenderness or enlargement
• Fluid retention
• Worsening of certain cases of sleep apnea
• Reduced testicular size
• Suppression of natural testosterone production
• Reduced sperm production and infertility

The rise in hematocrit is especially important. Too many red blood cells can make blood more viscous and may raise the risk of complications.

Men taking testosterone generally need periodic blood tests to monitor hematocrit, testosterone levels and, when appropriate, PSA.

Treatment should also be reconsidered if hormone levels normalize but symptoms do not improve. Why accept the cost, inconvenience and risks of a therapy that is not helping?

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 has historically discouraged the use of testosterone in older men, “even if a man’s symptoms seem related to low testosterone.” The agency used to warn 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?”

That is a decision between you and your physician. We cannot make any recommendations. As mentioned above, the FDA is loosening its restrictions, though.

Could GLP-1 Drugs Raise Testosterone Naturally?

Just as the FDA is reconsidering testosterone replacement, researchers are exploring another way to address low testosterone: treating the metabolic problems that may be causing it.

GLP-1 medicines such as semaglutide, liraglutide, dulaglutide and tirzepatide are prescribed for type 2 diabetes or obesity. You have no doubt heard of brand names such as Ozempic, Wegovy, Mounjaro and Zepbound.

Scientists are discovering that their effects may extend beyond blood sugar and weight loss.

At the Endocrine Society’s ENDO 2026 meeting in Chicago, researchers presented an analysis of studies evaluating GLP-1 drugs and male reproductive health. The investigators concluded that these medicines did not appear to suppress male reproductive hormones. In men with obesity-related low testosterone, some GLP-1 drugs were associated with improvements in testosterone or semen measurements.

The researchers cautioned that the evidence is limited and inconsistent. Larger randomized trials designed specifically to evaluate fertility will be needed. Nevertheless, the idea is intriguing.

Treating the Cause Instead of Replacing Testosterone

Obesity can contribute to low testosterone in several ways. Fat tissue contains the enzyme aromatase, which converts testosterone into estrogen. Obesity is also associated with inflammation, insulin resistance, sleep apnea and disruptions in the hormonal signals between the brain and testes.

Losing excess weight can sometimes allow natural testosterone production to recover. That creates two very different treatment strategies for men with obesity-related low T:

1. Replace testosterone directly.
2. Treat obesity and metabolic dysfunction and see whether testosterone recovers naturally.

The second approach may be particularly valuable for younger men who want to father children.

A treatment that improves metabolic health while preserving or improving sperm production would have an obvious advantage for some men. That does not mean GLP-1 drugs should now be prescribed as fertility medications. The research presented at ENDO 2026 is preliminary and should not be oversold.

But it supports an important principle: Before replacing a hormone, look for potentially reversible reasons why it is low.

Making Sense of the FDA Testosterone Reversal

Here is what the accumulating evidence appears to show:

• Testosterone therapy did not increase major cardiovascular events in appropriately selected men enrolled in the TRAVERSE trial.
• The FDA removed its boxed cardiovascular warning in 2025 but strengthened warnings about increased blood pressure.
• The agency is now requesting removal of the restriction involving age-related low testosterone.
• Clinical trial and epidemiologic evidence has not generally demonstrated that testosterone therapy causes prostate cancer.
• The proposed new prescribing information would warn about testosterone only in men with metastatic prostate cancer.
• Long-term prostate risks are not completely settled.
• Available trials have not shown that testosterone worsens mild to moderate BPH symptoms.
• Testosterone can raise hematocrit and blood pressure.
• Testosterone replacement can reduce sperm production.
• Weight loss and improved metabolic health may raise natural testosterone in some men with obesity.
• Men need symptoms plus consistently low morning testosterone measurements before treatment is considered.

Were Men Misled for a Decade?

The FDA made decisions in 2015 based on imperfect and conflicting evidence. Regulators should warn the public when they detect a serious safety signal. But warnings also have consequences.

A frightening government announcement can alter prescribing for years. Doctors may refuse treatment. Patients may reject a therapy that could have improved their symptoms and quality of life.

Once reassuring evidence accumulates, regulators have an obligation to respond promptly and clearly. The cardiovascular warning remained long after multiple studies had failed to confirm the feared danger. Even after the TRAVERSE trial provided the randomized evidence the FDA had demanded, the agency took nearly two more years to remove the boxed warning.

Now it is retreating from restrictions involving age-related low testosterone, prostate cancer and enlarged prostate. That certainly looks like an FDA Testosterone Reversal.

Perhaps the agency would say that science evolved and the labeling is evolving with it. That is true as far as it goes. But men and their physicians are entitled to ask whether regulators were too quick to frighten the public and too slow to correct the record.

The Bottom Line

Testosterone should not be portrayed as either a fountain of youth or a dangerous poison. It is a powerful hormone with genuine benefits and meaningful risks.

Men with symptoms should be evaluated carefully. That generally means at least two properly timed testosterone measurements and an effort to identify reversible causes such as obesity, sleep apnea, medication effects or uncontrolled diabetes.

Those who begin treatment should be monitored for symptom improvement, testosterone levels, hematocrit, blood pressure and prostate health when appropriate.

Men hoping to father children need to know that testosterone replacement can suppress sperm production.

The FDA’s old warnings encouraged fear. The new revisions should encourage something better: informed, individualized medical decisions based on current evidence rather than outdated dogma.

Final Words

What is your experience with testosterone? Did it improve your energy, mood, muscle strength or libido? Did a doctor discourage treatment because of concerns about heart disease or prostate cancer?

What do you think about the FDA’s recent flip-flop on cardiovascular risk? Perhaps you would be kind enough to share this testosterone update with some friends or family. It is a major change in policy at the Food and Drug Administration. Please share your story in the comment section below.