On 28 February 2025 the U.S. Food and Drug Administration notified sponsors of testosterone products of class-wide labeling changes, after reviewing the TRAVERSE trial and required postmarket ambulatory blood-pressure monitoring (ABPM) studies.
The agency removed language from the Boxed Warning that had described an increased risk of adverse cardiovascular outcomes, and required that a summary of the TRAVERSE results be added to all testosterone product labels. The 'Limitation of Use' language cautioning against treatment for age-related hypogonadism was retained.
At the same time, the FDA said the ABPM studies confirmed that testosterone products raise blood pressure class-wide. Products with completed ABPM studies must add specific blood-pressure data to their labels; products without a completed study must add a new warning about increased blood pressure.
The net effect narrows the cardiovascular caution around indicated testosterone therapy while introducing a new, explicit hypertension warning. The changes apply to prescription testosterone products used for classical hypogonadism, not to non-prescription or non-medical use.