WASHINGTON, D.C. — The Food and Drug Administration is seeking revisions to prescribing information for testosterone replacement therapies after concluding that newer clinical evidence no longer supports certain longstanding restrictions and warnings associated with the treatment.
The proposed labeling changes would affect how testosterone therapies are prescribed for men with low testosterone levels, update safety information related to prostate health, and reflect findings from more recent clinical research, the Department of Health and Human Services announced.
The most significant revision would remove a limitation stating that the safety and effectiveness of testosterone replacement therapy had not been established for men with age-related or idiopathic hypogonadism, a condition characterized by low testosterone levels without a known underlying cause.
The restriction was added in 2015 amid concerns about potential cardiovascular risks and limited evidence regarding treatment benefits.
Since then, FDA has reviewed additional research, including the TRAVERSE trial, a large study involving more than 5,200 men. According to the agency, the trial found no meaningful increase in major adverse cardiovascular events, including heart attacks and strokes, among patients receiving testosterone therapy.
Based on those findings and other available evidence, FDA determined the limitation of use is no longer warranted.
“FDA’s responsibility is to ensure prescribing information reflects the best available scientific evidence,” Michael Davis, acting director of FDA’s Center for Drug Evaluation and Research, stated. “These updates provide patients and healthcare professionals with clearer information about the benefits and risks of testosterone replacement therapy and support informed treatment decisions.”
The agency is also requesting revisions to prostate cancer warnings that have long appeared on testosterone product labels.
Current labeling generally warns that testosterone therapy may increase the risk of developing prostate cancer and advises against use in men with known or suspected disease. Under the proposed changes, testosterone therapy would be contraindicated only for men with metastatic prostate cancer.
FDA noted that available clinical trials and epidemiological studies have generally not demonstrated an increased risk of prostate cancer among men receiving testosterone therapy. However, the agency cautioned that uncertainty remains because prostate cancer can take years to develop and many studies have not followed patients long enough to assess long-term outcomes.
The revised labeling would continue to recommend prostate cancer screening before treatment and ongoing monitoring during therapy.
The agency is also seeking updates to warnings regarding benign prostatic hyperplasia, commonly known as an enlarged prostate.
Current prescribing information warns that testosterone therapy may worsen symptoms associated with the condition. FDA’s review found that clinical trial data did not demonstrate worsening symptoms among men with mild to moderate benign prostatic hyperplasia, although evidence remains limited for patients with severe disease. Under the proposed revisions, healthcare providers would be advised to continue monitoring patients with severe symptoms during treatment.
“During Men’s Health Month, we are putting science back at the center of men’s healthcare,” HHS Secretary Robert F. Kennedy Jr. stated. “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.”
The requested changes follow a comprehensive FDA review of clinical data and scientific literature and represent one of the agency’s most significant updates to testosterone replacement therapy labeling in more than a decade.
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