Labeling Changes for Testosterone Products: FDA

FDA says it has ordered testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men using them for hypogonadism. An agency notice says the warning can be removed based on findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial.

Additionally, labeling changes are required on testosterone products based on data from postmarket ambulatory blood pressure (ABPM) studies, including adding product-specific information and a new warning on increased blood pressure for testosterone products which currently do not have such a warning in their labeling, according to the notice.

Testosterone is approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.