Testosterone Replacement Therapy: FDA Labeling Updates Clarify Cardiovascular, Prostate, and BPH Risks

Sep 1

3 min read

Updated: Sep 2

Testosterone Replacement Therapy: What Men Should Know About the FDA’s Updated Guidance

At Egan Wellness & Med Spa, we believe men deserve clear, evidence-based information when considering testosterone replacement therapy (TRT). Recent FDA labeling updates provide important clarification about cardiovascular health, prostate concerns, and urinary symptoms associated with testosterone therapy.

What Has Changed About Heart Health?

One of the biggest changes involves cardiovascular risk.

The TRAVERSE trial followed more than 5,200 men with hypogonadism who had cardiovascular disease or multiple cardiovascular risk factors. Major cardiovascular events occurred in 7.0% of men receiving testosterone compared with 7.3% receiving placebo. The FDA concluded that the study did not demonstrate a new cardiovascular safety signal or increased risk of major adverse cardiovascular events.

This does not mean testosterone is risk-free. FDA labeling continues to warn that testosterone can increase blood pressure, and blood pressure should be monitored during treatment.

At Egan Wellness, cardiovascular risk is considered as part of the whole patient—not simply a testosterone number.

What About Prostate Cancer?

The FDA has also updated testosterone labeling to provide more specific information regarding prostate cancer and benign prostate enlargement.

Current evidence has not established that appropriately prescribed testosterone therapy increases the incidence of prostate cancer. However, men with known or suspected prostate cancer require careful evaluation before considering TRT, and prostate health should continue to be monitored during treatment.

For men with a history of prostate cancer, treatment decisions are individualized. Factors such as the type and risk level of the original cancer, treatment history, PSA trends, and current urologic evaluation all matter. Long-term safety data are still limited in some higher-risk groups.

Does Testosterone Make BPH or Urinary Symptoms Worse?

Many men have been told that testosterone will automatically worsen an enlarged prostate or urinary symptoms. The evidence is more nuanced.

In men with mild-to-moderate BPH and lower urinary tract symptoms (LUTS), available evidence has generally not demonstrated significant worsening with testosterone therapy. In TRAVERSE, testosterone did not significantly increase acute urinary retention, the need for new urinary medications, or worsening of urinary symptom scores compared with placebo.

However, men with severe urinary symptoms were excluded from TRAVERSE, so these results should not automatically be applied to every man with BPH.

What Does This Mean for Men Considering TRT?

The conversation around testosterone therapy is becoming more evidence-based.

Rather than assuming that testosterone automatically causes heart attacks, prostate cancer, or worsening urinary symptoms, we should look at the individual patient, his symptoms, laboratory results, medical history, cardiovascular risk, prostate health, and treatment goals.

At Egan Wellness & Med Spa, our approach includes appropriate evaluation and ongoing monitoring. Depending on the individual patient, this may include:

Testosterone and related laboratory testing
Blood pressure monitoring
Hematocrit/hemoglobin monitoring
PSA and appropriate prostate screening
Assessment of urinary symptoms
Review of cardiovascular risk factors
Monitoring testosterone levels to keep treatment within the intended therapeutic range

Testosterone Therapy Should Be Individualized

TRT can be an important treatment option for appropriately diagnosed men with testosterone deficiency, but it is not appropriate for everyone. FDA-approved testosterone products are intended for men with testosterone deficiency associated with an underlying medical condition, and treatment should be based on appropriate clinical evaluation.

At Egan Wellness & Med Spa, Dr. Pamela Egan, DNP, MS, MN, CDCES, ABAAHP Diplomat, Board Certified Adult & Family Nurse Practitioner, focuses on helping patients understand both the potential benefits and the potential risks of hormone therapy.

The goal isn't simply to raise testosterone. The goal is to help the right patient achieve better health, function, vitality, and quality of life—while monitoring safety along the way.