HHS Announces Requested Updates to Testosterone Therapy Product Labels

The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone replacement therapy products following a comprehensive review of new clinical data and existing scientific evidence.

The proposed changes would:

• Remove the limitation of use stating that 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.
• Revise warnings regarding benign prostatic hyperplasia, also known as enlarged prostate.

"During Men's Health Month, we are putting science back at the center of men's healthcare," said HHS Secretary Robert F. Kennedy, Jr. "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."

"As our understanding of testosterone therapy continues to evolve, prescribing information should reflect the best available science," said Brian J. Christine, M.D., Assistant Secretary for Health. "This action helps ensure patients and healthcare providers have accurate, up-to-date information when considering treatment options."

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, a condition involving low testosterone levels without a known underlying cause. The limitation was added because evidence of benefit was limited and concerns had been raised about possible cardiovascular risks.

Since then, 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.

FDA is also requesting updates to longstanding safety information related to prostate health.

Current labeling generally states that testosterone replacement therapy should not be used in men with known or suspected prostate cancer and warns that treatment may increase the risk of developing prostate cancer. Under the requested revisions, testosterone replacement therapy would be contraindicated only in men with metastatic prostate cancer.

Available clinical trial and epidemiologic data have not generally shown an increased risk of prostate cancer in men receiving testosterone replacement therapy. However, important uncertainties remain because prostate cancer can take years to develop and existing studies may not have followed patients long enough to detect long-term effects. The proposed labeling continues to recommend that healthcare providers assess risk, screen patients before treatment and monitor patients during therapy.

FDA is also requesting updates to labeling information related to benign prostatic hyperplasia. Current labeling generally warns that testosterone replacement therapy may worsen symptoms of the condition. FDA's 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 labeling changes requested would recommend continued monitoring of patients with severe symptomatic disease during treatment.

"FDA's responsibility is to ensure prescribing information reflects the best available scientific evidence," said Michael Davis, M.D., Ph.D., acting director of FDA's Center for Drug Evaluation and Research. "These updates provide patients and healthcare professionals with clearer information about the benefits and risks of testosterone replacement therapy and support informed treatment decisions."

Today's action reflects HHS' commitment to ensuring that prescribing information evolves alongside scientific evidence, giving patients and healthcare providers access to the most accurate and current information available.