The updated labeling will now include findings from the TRAVERSE trial, which determined no increased risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism, according to a Feb. 28 news release from the agency.
However, the FDA will maintain the “limitation of use” language for age-related hypogonadism and remove previous box warning language about cardiovascular risks.
In addition, based on postmarket ambulatory blood pressure studies, the FDA is requiring new warnings about increased blood pressure for all testosterone products and product-specific information added for those with completed studies.
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