HHS and the FDA have requested updates to prescribing information for testosterone replacement therapy products, including changes related to age-related hypogonadism, prostate cancer risk and benign prostatic hyperplasia.
HHS said it plans to remove a limitation of use stating that the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism had not been established, according to a June 18 news release. The restriction was added in 2015 because evidence of benefit was limited and concerns had been raised about possible cardiovascular risks.
The proposed changes follow a review of new clinical data, including the Traverse trial, which involved more than 5,200 men. The trial found no meaningful increase in the risk of major adverse cardiovascular events, including heart attack and stroke, among men receiving testosterone replacement therapy. The Traverse trial data also informed a round of FDA labeling updates in March 2025, when the agency added new blood pressure warnings to all testosterone products while maintaining the age-related hypogonadism limitation of use — a restriction now proposed for removal.
The FDA also requested revisions to long-standing prostate health warnings. Under the proposed labeling, testosterone replacement therapy would be contraindicated only in men with metastatic prostate cancer. Current labeling generally states that the therapy should not be used in men with known or suspected prostate cancer.
The agency also plans to revise warnings related to benign prostatic hyperplasia. FDA said available clinical trial data did not demonstrate worsening symptoms in men with mild to moderate benign prostatic hyperplasia, though evidence remains limited for men with severe symptoms.
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