US health department proposes testosterone therapy label updates

The U.S. health department said on Thursday it was seeking updates to labels for testosterone replacement therapies after reviewing new clinical data and other evidence.

The proposed changes would remove limits on use in men with age-related low testosterone, revise warnings on enlarged prostate and update information related to prostate cancer risk, the U.S. Department of Health and Human Services said.

The move could make it easier for doctors to prescribe the therapy to a wider group of men and marks the latest effort by the department under the Trump administration to ease restrictions on hormonal treatments.

In 2015, the U.S. Food and Drug Administration had required testosterone therapy labels to state that the safety and effectiveness of the treatment had not been established in men with signs and symptoms associated with idiopathic hypogonadism, a condition involving low testosterone levels without a known underlying cause.

The HHS said newer evidence, including a large study of more than 5,200 men, found no meaningful increase in the risk of major heart-related events, such as heart attack and stroke, among men receiving testosterone therapy.

Based on its review of these findings and other available evidence, the FDA has concluded that the limitation of use is no longer warranted, the agency said.

Current labels of testosterone replacement therapies warn that their use may increase the risk of developing prostate cancer. However, under the new FDA revisions, the therapies would be recommended against men with metastatic prostate cancer.

(Reporting by Kunal Das in Bengaluru; Editing by Anil D'Silva)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 18, 2026 at 3:10 PM.