FDA Issues New Safety Labeling Requirements for Testosterone Products: What It Means for TRT Patients
In February 2025, the U.S. Food and Drug Administration (FDA) announced significant updates to the safety labeling of all testosterone replacement therapy (TRT) products. These changes reflect new clinical data on cardiovascular and blood pressure risks associated with testosterone use and have implications for both patients currently receiving TRT and those considering treatment.
Understanding these updates is essential for clinicians and patients navigating the appropriate and safe use of hormone therapy in the treatment of male hypogonadism.
Why the FDA Updated Testosterone Product Labels
The FDA’s decision was informed by two major bodies of research:
- The TRAVERSE Trial, a multi-year study evaluating the cardiovascular safety of TRT in men with hypogonadism.
- Ambulatory Blood Pressure Monitoring (ABPM) studies, which examined the effects of testosterone therapy on blood pressure.
Combined, these studies offered robust data that prompted the FDA to re-evaluate the risk profile of testosterone products across the board.
Summary of the New FDA Requirements
Labeling for all testosterone products now includes:
- Results from the TRAVERSE Trial, which found no increase in major adverse cardiovascular events (MACE) among TRT users.
- Continued inclusion of the “Limitation of Use” statement: testosterone is not FDA-approved for age-related testosterone decline without a clear underlying medical condition.
- Removal of the Boxed Warning about cardiovascular risk.
- Addition of blood pressure warnings:
- Products with completed ABPM studies must include specific blood pressure data.
- Products without ABPM data must include a general warning regarding potential blood pressure increases.
TRT: Indications and Considerations
Testosterone replacement therapy is approved for men with clinically diagnosed hypogonadism, a condition marked by the body’s inability to produce adequate levels of testosterone. Common causes include:
- Primary testicular failure
- Pituitary or hypothalamic dysfunction
- Injury, illness, or medical treatment affecting hormone production
Symptoms of hypogonadism can include fatigue, low libido, erectile dysfunction, loss of muscle mass, weight gain, and depressed mood.
TRT is not recommended for men experiencing testosterone decline due solely to aging. Proper diagnosis through clinical evaluation and lab testing is essential before initiating therapy.
Treatment options vary and may include:
- Transdermal gels or patches
- Oral formulations
- Buccal tablets
- Injections (intramuscular or subcutaneous)
Each delivery method has its own risk profile, absorption pattern, and monitoring requirements.
Cardiovascular Risk: Insights from the TRAVERSE Trial
Previously, concerns existed regarding potential cardiovascular risks associated with TRT. The TRAVERSE Trial was launched to examine this directly. It followed men with confirmed hypogonadism over several years and assessed outcomes such as heart attack, stroke, and related cardiac events.
The findings, published in 2023, showed no increased risk of major cardiovascular events in men receiving testosterone therapy compared to those receiving a placebo. This outcome played a central role in the FDA’s decision to eliminate the previous Boxed Warning for cardiovascular risk.
Blood Pressure Considerations: New Warning Requirements
While TRT did not show elevated cardiovascular risk in the TRAVERSE trial, ABPM studies demonstrated a mild but consistent increase in blood pressure in many testosterone users.
The FDA now mandates that all testosterone product labels include a blood pressure warning, tailored to the product’s specific data when available. This reflects a growing consensus that routine blood pressure monitoring is a critical component of safe TRT management.
Clinical Takeaways for TRT Patients and Providers
The recent labeling changes reinforce several best practices for safe and effective testosterone therapy:
- TRT should only be used in medically indicated cases, based on confirmed laboratory and clinical findings.
- Monitoring protocols should include regular cardiovascular assessments, including blood pressure and lipid panels.
- Patient education is critical, especially around potential side effects and proper use of testosterone products.
While the new data are reassuring in terms of cardiovascular risk, the updates highlight the importance of individualized treatment plans and ongoing monitoring.
These developments represent a step forward in aligning testosterone therapy with current clinical evidence. For patients, they serve as a reminder that TRT, while beneficial in the right context, is a medical therapy that should be approached with the same rigor and caution as any other hormone-based treatment.
Sources
- U.S. Food & Drug Administration. FDA requires labeling changes for all testosterone products to include new safety information. February 28, 2025. FDA.gov
- N Engl J Med. Cardiovascular Safety of Testosterone Replacement Therapy. 2023. TRAVERSE Study results. nejm.org
- U.S. Food & Drug Administration. Summary Basis for Regulatory Action: Testosterone Products and Blood Pressure Warnings. 2024.
- JAMA Intern Med. Blood Pressure Changes Associated With Testosterone Therapy: A Meta-Analysis of ABPM Studies. 2022.
