FDA removes heart risk warning from testosterone products

The US Food and Drug Administration has issued new labeling changes for all approved testosterone replacement therapy products, removing a previous black box warning about cardiovascular risks while adding a new warning about increased blood pressure.

The decision follows the agency’s review of the TRAVERSE clinical trial and postmarket blood pressure studies, with data showing no increased risk of major adverse cardiovascular events for those using testosterone therapy compared to a placebo.

Based on these findings, the FDA recommended that all testosterone products include the TRAVERSE trial results in their labeling.