FDA Wants Testosterone Therapy Labels Updated

FDA is requesting updates to the prescribing information for testosterone replacement therapy products following what it calls a comprehensive review of clinical data and existing scientific evidence. A HHS news release says the labeling changes would:

• remove the limitation of use that says the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism have not been established;
• update information related to prostate cancer risk; and
• revise Warnings about benign prostatic hyperplasia.

HHS says that in 2015, FDA required testosterone replacement therapy product labeling to include a limitation of use stating that safety and effectiveness had not been established in men with signs and symptoms associated with idiopathic hypogonadism. The limitation was added, it says, because evidence of benefit was limited and concerns had been raised about possible cardiovascular risks.

“Since then,” the release continues, “additional evidence has become available, including the TRAVERSE trial, a large clinical study involving 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. Based on its review of these findings and other available evidence, FDA has concluded that the limitation of use is no longer warranted.”

In the updated labeling on prostate cancer, testosterone replacement therapy would be contraindicated only in men with metastatic prostate cancer.

Finally, the agency says its review found that available clinical trial data do not demonstrate worsening symptoms in men with mild to moderate benign prostatic hyperplasia, although evidence remains limited for men with severe symptoms. The requested labeling changes would recommend continued monitoring of patients with severe symptomatic disease during treatment, HHS says.

The release quotes HHS secretary Robert F. Kennedy Jr. as saying that “During Men’s Health Month, we are putting science back at the center of men’s healthcare. By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.”

CDER acting director Michael Davis says the updates will “provide patients and healthcare professionals with clearer information about the benefits and risks of testosterone replacement therapy and support informed treatment decisions.”