In February 2025, the U.S. Food and Drug Administration (FDA) announced class-wide labeling changes for testosterone products, reflecting new clinical evidence regarding their cardiovascular safety profile. These updates are poised to influence medical practices and patient care significantly.
Historical Context of FDA Labeling for Testosterone Products
Testosterone replacement therapy (TRT) has been under scrutiny due to concerns about cardiovascular risks. In January 2014, the FDA issued a Drug Safety Communication warning of potential risks such as stroke, heart attack, and death associated with testosterone use. This led to a mandate for manufacturers to conduct extensive studies to assess these risks. [1] By March 2015, the FDA required labeling changes to inform users of possible increased cardiovascular risks and cautioned against using testosterone products for age-related testosterone decline. [2]
Recent Changes in FDA Requirements
The recent labeling changes stem from findings of the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial and post-market ambulatory blood pressure monitoring (ABPM) studies. Key updates include:
- Incorporation of TRAVERSE Trial Results: Labels now include data from the TRAVERSE trial, which found no significant increase in adverse cardiovascular outcomes, such as myocardial infarction and stroke, in men using testosterone for hypogonadism.
- Removal of Boxed Warning: The previous boxed warning about increased cardiovascular risks has been removed from all testosterone product labels.
- Blood Pressure Warnings: Based on ABPM studies indicating that testosterone use can lead to increased blood pressure, new warnings have been added to product labels.
- Limitation of Use: The “Limitation of Use” language for age-related hypogonadism has been retained, emphasizing that the safety and efficacy of testosterone therapy for age-related testosterone decline remain unestablished, and thus, an off-label use. [3]
Implications for Medical Practice and Patient Care
These labeling changes are expected to influence both healthcare providers and patients:
- Increased Prescribing Confidence: The removal of the boxed warning may alleviate concerns among physicians regarding cardiovascular risks, potentially leading to more widespread prescribing of testosterone therapy for men with clinically diagnosed hypogonadism. [4]
- Enhanced Patient Monitoring: The addition of blood pressure warnings underscores the need for regular monitoring of cardiovascular health in patients undergoing TRT, ensuring early detection and management of potential hypertension.
- Patient Education: Healthcare providers must educate patients about the benefits and risks of TRT, emphasizing the importance of adherence to monitoring protocols and lifestyle modifications to mitigate risks.
Overall, these FDA updates aim to balance the therapeutic benefits of testosterone replacement therapy with patient safety, fostering informed decision-making in clinical practice.
At Carie Boyd Pharmaceuticals, we are dedicated to supporting healthcare providers with high-quality, customized solutions for Hormone Replacement Therapy. We offer a variety of testosterone dosage forms—pellets, tablets, troches, creams, and injections—available as Testosterone Cypionate or a Cypionate/Propionate blend, all precisely formulated.
References:
1. U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. January 2014. Available at: https://wayback.archive-it.org/
2. U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging. March 2015. Available at: https://www.fda.gov/drugs/
3. U.S. Food and Drug Administration (FDA). FDA issues class-wide labeling changes for testosterone products. February 2025. Available at: https://www.fda.gov/
4. Medscape. Physicians welcome testosterone labeling changes. February 2025. Available at: https://www.medscape.com/
