FDA mandates new labeling for all testosterone products

On February 28, FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial and results from required postmarket ambulatory blood pressure (ABPM) studies.

Led by the TRAVERSE trial’s results, FDA is recommending changes to current labeling language, to include:

• adding results of the TRAVERSE trial to all testosterone products;
• retaining “Limitation of Use” language for age-related hypogonadism; and
• removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products.

Led by results of the ABPM studies, FDA is also requiring changes to current labeling language, to include:

• adding product-specific information on increased BP for testosterone products with completed ABPM studies;
• adding a new warning about increased BP for testosterone products which currently don't have such a warning in their labeling.

Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch, buccal system, and injection.

Source:

(2025, February 28). FDA. FDA issues class-wide labeling changes for testosterone products. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products