madman
Super Moderator
* It is important to note that long-term studies including TRAVERSE, T4DM, and T-Trials have not demonstrated blood pressure increases at periods of one year or greater. The Androgen Society acknowledges that these findings warrant careful consideration in the implementation of blood pressure-related labeling changes.
* The FDA's recommended changes regarding the cardiovascular safety of testosterone therapy align with The Androgen Society's Position Statement published in the November 2024 issue of Mayo Clinic Proceedings (Morgentaler A, Dhindsa S, Dobs AS, Hackett G, Jones TH, Kloner RA, Miner M, Zitzmann M, Traish AM).
www.androgensociety.org
The Androgen Society Endorses FDA's Class-Wide Labeling Changes for Testosterone Products
March 5, 2025 - The Androgen Society welcomes the U.S. Food and Drug Administration's (FDA) recent announcement regarding class-wide labeling changes for testosterone products. These changes reflect important new clinical evidence and align with The Androgen Society's position on the cardiovascular safety of testosterone therapy.
Key Labeling Changes
Based on recent findings from the TRAVERSE trials, the FDA is implementing several significant changes to testosterone product labeling:
Additionally, following Ambulatory Blood Pressure Monitoring (ABPM) studies, the FDA is requiring:
Scientific Context
It is important to note that long-term studies including TRAVERSE, T4DM, and T-Trials have not demonstrated blood pressure increases at periods of one year or greater. The Androgen Society acknowledges that these findings warrant careful consideration in the implementation of blood pressure-related labeling changes.
The FDA's recommended changes regarding the cardiovascular safety of testosterone therapy align with The Androgen Society's Position Statement published in the November 2024 issue of Mayo Clinic Proceedings (Morgentaler A, Dhindsa S, Dobs AS, Hackett G, Jones TH, Kloner RA, Miner M, Zitzmann M, Traish AM).
The Androgen Society continues to support evidence-based guidelines for testosterone therapy and remains committed to advancing research and education on the safe and effective use of testosterone products.
* The FDA's recommended changes regarding the cardiovascular safety of testosterone therapy align with The Androgen Society's Position Statement published in the November 2024 issue of Mayo Clinic Proceedings (Morgentaler A, Dhindsa S, Dobs AS, Hackett G, Jones TH, Kloner RA, Miner M, Zitzmann M, Traish AM).
The Androgen Society Endorses FDA's Class-Wide Labeling Changes for Testosterone Products
The Androgen Society Endorses FDA's Class-Wide Labeling Changes for Testosterone Products
March 5, 2025 - The Androgen Society welcomes the U.S. Food and Drug Administration's (FDA) recent announcement regarding class-wide labeling changes for testosterone products. These changes reflect important new clinical evidence and align with The Androgen Society's position on the cardiovascular safety of testosterone therapy.
Key Labeling Changes
Based on recent findings from the TRAVERSE trials, the FDA is implementing several significant changes to testosterone product labeling:
- Addition of TRAVERSE trial results to all testosterone product labels
- Retention of "Limitation of Use" language for age-related hypogonadism
- Removal of language from the Boxed Warning related to increased risk of adverse cardiovascular outcomes
Additionally, following Ambulatory Blood Pressure Monitoring (ABPM) studies, the FDA is requiring:
- Product-specific information on increased blood pressure for testosterone products with completed ABPM studies
- A new warning about increased blood pressure for testosterone products that currently lack such warnings
Scientific Context
It is important to note that long-term studies including TRAVERSE, T4DM, and T-Trials have not demonstrated blood pressure increases at periods of one year or greater. The Androgen Society acknowledges that these findings warrant careful consideration in the implementation of blood pressure-related labeling changes.
The FDA's recommended changes regarding the cardiovascular safety of testosterone therapy align with The Androgen Society's Position Statement published in the November 2024 issue of Mayo Clinic Proceedings (Morgentaler A, Dhindsa S, Dobs AS, Hackett G, Jones TH, Kloner RA, Miner M, Zitzmann M, Traish AM).
The Androgen Society continues to support evidence-based guidelines for testosterone therapy and remains committed to advancing research and education on the safe and effective use of testosterone products.
