FDA Mandates Class-Wide Labeling Changes for Testosterone Products Based on New Safety Data
Last updated 2026-08-06 · Source: fda.gov
Primary source: fda.gov: FDA Mandates Class-Wide Labeling Changes for Testosterone Products Based on New Safety Data
The FDA has announced significant class-wide labeling changes for all approved testosterone products. These updates incorporate findings from the TRAVERSE clinical trial, removing the Boxed Warning related to increased cardiovascular risk, and add new warnings regarding increased blood pressure based on postmarket studies.
What this means for your practice
These updated labeling requirements carry substantial implications for healthcare practices that prescribe testosterone, including men's health clinics, medspas, and general practitioners. While the removal of the cardiovascular risk from the Boxed Warning may alleviate some prior concerns, the new mandatory warning about increased blood pressure necessitates careful patient counseling and monitoring. Providers must update their informed consent processes and patient education materials to reflect these changes, emphasizing the continued 'Limitation of Use' language for age-related hypogonadism, meaning testosterone is not approved solely for age-related 'low T' without an associated medical condition. Vigilant blood pressure monitoring for patients on testosterone therapy will be critical to ensure compliance and patient safety. Practices should review their protocols to align with these federal guidelines.
Washington D.C. — On February 28, 2025, the U.S. Food and Drug Administration (FDA) informed sponsors of all FDA-approved testosterone products about new, class-wide labeling changes. These updates are a direct result of the agency's comprehensive review of recent clinical data, specifically the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and required postmarket ambulatory blood pressure monitoring (ABPM) studies.
Background on FDA's Review and Prior Actions
Testosterone, a hormone vital for male growth and masculine characteristics, is approved for use exclusively in men who have low testosterone levels coupled with an associated medical condition. The FDA's scrutiny of testosterone product safety has been ongoing for several years. In September 2014, the agency convened a Joint Meeting of its Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management Advisory Committee. This meeting followed an increase in reports of serious adverse events, including stroke, heart attack, and death, in men using FDA-approved testosterone products.
This led to an FDA recommendation for an industry-wide clinical trial to rigorously assess the cardiovascular safety of testosterone use, particularly in men with age-related hypogonadism. Additionally, concerns regarding blood pressure emerged from premarket ABPM studies for two distinct testosterone products in 2016 and 2017. By March 2018, the FDA had issued a postmarket requirement for individual ABPM studies for all testosterone products.
Prior FDA actions also include a January 2014 Drug Safety Communication (DSC) warning of reported risks and a March 2015 DSC informing of required labeling changes and urging caution for use in low testosterone due to aging.
Key Findings Driving the Labeling Changes
The TRAVERSE Clinical Trial
Results from the TRAVERSE trial, submitted in 2023, played a pivotal role in the cardiovascular safety assessment. This extensive trial concluded that there was no increase in the risk of adverse cardiovascular outcomes in men utilizing testosterone for hypogonadism. This finding directly contradicts some earlier concerns and reports.
Ambulatory Blood Pressure Monitoring (ABPM) Studies
In contrast to the TRAVERSE trial's cardiovascular findings, the results from the completed postmarket ABPM studies confirmed a consistent and concerning trend: an increase in blood pressure with the use of all testosterone products, class-wide. This finding solidified the need for new warnings regarding this specific risk.
Specific Labeling Changes Mandated by the FDA
Based on these comprehensive reviews, the FDA is mandating the following class-wide changes to testosterone product labeling:
- Addition of TRAVERSE Trial Results: The full results of the TRAVERSE trial must now be included in the labeling for all testosterone products.
- Retention of 'Limitation of Use' Language: The existing language limiting the use of testosterone for age-related hypogonadism will be retained. This reinforces that testosterone therapy is not indicated for treating low testosterone solely due to aging without an associated medical condition.
- Removal of Boxed Warning Regarding Cardiovascular Risk: Due to the TRAVERSE trial findings, language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes will be removed from all testosterone products.
- Addition of Blood Pressure Warnings:
Implications for Healthcare Professionals and Patients
These labeling changes represent a significant update to the risk-benefit profile of testosterone therapy. Healthcare professionals are encouraged to review the updated labeling carefully and integrate this new information into their clinical decision-making. While the previous cardiovascular concerns in the Boxed Warning have been addressed by the TRAVERSE trial, the new class-wide warning about increased blood pressure demands heightened awareness and monitoring during treatment.
Patients should discuss any concerns with their healthcare providers. The FDA continues to encourage both health care professionals and patients to report any adverse events or quality problems experienced with medication use to the FDA’s MedWatch Adverse Event Reporting program.
Key Facts
| Detail | Value | |---|---| | Action | FDA mandates class-wide labeling changes for all testosterone products. | | Date of Announcement | February 28, 2025 | | Basis for Changes | TRAVERSE clinical trial results and postmarket ABPM studies. | | Cardiovascular Risk Update | Removal of Boxed Warning language related to increased cardiovascular risk. | | New Warning Added | Increased blood pressure warning for all testosterone products. | | Approval Scope | Testosterone approved solely for men with low levels and an associated medical condition; 'Limitation of Use' for age-related hypogonadism retained. |
Frequently Asked Questions
What are the primary changes to testosterone product labels?
The main changes include removing language about increased cardiovascular risk from the Boxed Warning and adding new warnings about increased blood pressure for all testosterone products.
Why is the FDA making these labeling changes now?
The changes are based on the FDA's review of findings from the TRAVERSE clinical trial, which assessed cardiovascular safety, and results from required postmarket ambulatory blood pressure monitoring (ABPM) studies.
Does this mean testosterone is now considered safer for cardiovascular health?
The TRAVERSE clinical trial concluded there was no increase in the risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism, leading to the removal of this risk from the Boxed Warning.
What new risks are being added to the labels?
A new class-wide warning about increased blood pressure is being added, as results from ABPM studies confirmed an increase in blood pressure with the use of all testosterone products.
Is testosterone approved for general 'low T' due to aging?
No, the 'Limitation of Use' language for age-related hypogonadism is being retained, meaning testosterone is approved solely for men who lack or have low testosterone levels in conjunction with an associated medical condition.