Testosterone therapy labels and limits may change under FDA proposal

by Ellyn Vohnoutka

edited by Stephanie Baum, reviewed by Andrew Zinin

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The U.S. Food and Drug Administration (FDA) is asking drugmakers to update the prescribing information on testosterone replacement therapy products to reflect newer clinical evidence.

The U.S. Department of Health and Human Services (HHS) announced a request through the FDA to change how the labels describe the treatment's risks and who can safely use it.

Three main updates are proposed.

First, the FDA wants to remove a limitation stating that the therapy's safety and effectiveness have not been established in men with age-related low testosterone, also called hypogonadism. That language was added in 2015, when evidence of benefit was limited, and questions had been raised about possible heart risks.

After that, a large study known as the TRAVERSE trial followed more than 5,200 men and found no meaningful rise in major cardiovascular events, including heart attack and stroke, among those taking testosterone. Based on that and other evidence, regulators concluded the limitation is no longer warranted, HHS said in its announcement.

Second, the changes would ease longstanding warnings about the use of the hormone therapy in those with prostate cancer. Current labels say testosterone should not be used in men with known or suspected prostate cancer and warn that it may raise the risk of developing the disease. Under the proposed changes, the therapy would be off-limits only for men with metastatic prostate cancer.

Clinical and population studies have generally not shown a higher risk of prostate cancer in men using the therapy, according to HHS. Still, uncertainties remain because prostate cancer can take years to develop, and some studies may not have tracked patients long enough, HHS said. The revised labeling would continue to advise providers to assess risk, screen men before treatment and monitor them during it.

Third, the FDA wants to revise warnings about benign prostatic hyperplasia (enlarged prostate). Current labels warn that testosterone may worsen symptoms. The review found no such worsening in men with mild to moderate disease, though evidence is limited for severe cases, HHS states. The updated labeling would recommend continued monitoring for men with severe symptoms.

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

Dr. Brian Christine, HHS assistant secretary for health, said prescribing information should reflect the best available science as understanding of the treatment evolves.

More information

Visit the Cleveland Clinic for more on testosterone replacement therapy.

Key medical concepts

Metastatic Prostate CarcinomaHypogonadismEnlarged Prostate (BPH)

Clinical categories

Clinical pharmacologyMen's healthUrology Who's behind this story?

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