FDA Advisers Recommend Restricting Use of Testosterone Products

By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

An FDA advisory panel voted on Wednesday to limit the use of testosterone replacement therapies to men with medically related low testosterone — for example, due to a genetic condition or malignancy — Reuters reports.

If the FDA follows the panel's advice, manufacturers could no longer market their products to treat age-related low testosterone, although clinicians could still prescribe it off-label for this indication.

Over half of the panel members also recommended that additional safety studies be performed to evaluate cardiovascular risk in men using testosterone products for age-related low testosterone.