Understanding the Recent FDA Label Change on Testosterone Therapy: What It Means for You

Testosterone therapy has long been a topic of both interest and controversy in medicine, especially for men with symptoms of hypogonadism such as fatigue, low libido, mood changes, and reduced muscle mass. As part of our commitment to staying at the forefront of personalized, evidence-based care, I wanted to share some important updates regarding the FDA’s recent label changes on testosterone products.

Background: Why Was Testosterone Under Scrutiny?

For years, concerns were raised about a possible link between testosterone replacement therapy (TRT) and increased cardiovascular risk, particularly heart attacks, strokes, and venous thromboembolism (VTE). In 2015, the FDA issued a safety communication and added a boxed warning (the strongest warning issued by the FDA) on prescription testosterone products.

This was based on observational data, which can show associations but not causation. The FDA also emphasized that testosterone products were only approved for classic hypogonadism—conditions like primary testicular failure or pituitary dysfunction—not for “age-related” testosterone decline.

What Changed? The TRAVERSE Trial

In 2023, the landmark TRAVERSE trial (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men) was published in the New England Journal of Medicine. This randomized, double-blind, placebo-controlled trial followed 5,246 men aged 45 to 80 with hypogonadism and pre-existing cardiovascular risk factors for an average of 22 months.

Key Findings:

• There was no significant increase in major adverse cardiovascular events (MACE)—defined as heart attack, stroke, or cardiovascular death—between the testosterone and placebo groups.

• There was no increased risk of venous thromboembolism.

• Some improvements were observed in sexual function, bone density, and anemia.

  
  

As a result, On February 28, 2025, the FDA announced new labeling changes for testosterone products, including the removal of the black box warning regarding adverse cardiovascular outcomes.

New Warning: Blood Pressure Elevation

While the cardiovascular risk warning was removed, the FDA added a new class-wide warning based on data from ambulatory blood pressure monitoring studies.

Specifically:

• Some testosterone formulations—particularly testosterone undecanoate and testosterone enanthate—have shown clinically meaningful increases in systolic blood pressure.

• Even modest increases in blood pressure (2–4 mmHg) can increase long-term cardiovascular risk in men, especially those with existing hypertension or atherosclerotic disease.

What This Means at Vitality

At Vitality, testosterone is not just a hormone, but as part of a broader ecosystem that includes metabolic health, sleep, inflammation, gut health, and nutrient status.

This FDA update supports what we’ve already seen clinically:

• In properly selected patients, testosterone therapy can significantly enhance quality of life, improve muscle mass and strength, insulin sensitivity, and cognitive function.

• However, individualized risk stratification and regular monitoring are essential.

If you have any concerns about your current testosterone regimen—or if you’re interested in discussing whether you may be a candidate for therapy—please reach out to our office to schedule a personalized consultation.

Your health is unique. Your care should be too.