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How urologists can discuss testosterone labeling changes with patients
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"I hope that these new guidelines and the removal of the black box warning on testosterone therapy will help more physicians feel comfortable providing testosterone therapy to men," says Helen L. Bernie, DO, MPH.
With the FDA’s recent announcement of class-wide labeling changes for testosterone products,1 urologists will have new information to discuss with their patients.
In an interview with Urology Times®, Helen L. Bernie, DO, MPH, discussed her approach to patient counseling.
“When I have patients come into the office with me, I really just explain to them that sometimes bad data gets out, and it can take…many, many great studies and [a lot of] effort and time to really erase that,” said Bernie, director of sexual and reproductive medicine at Indiana University and an assistant professor of urology at Indiana University School of Medicine in Indianapolis, Indiana.
She said she discusses flawed studies of testosterone therapy.
“I explain to them that these studies had very poor methodology. In fact, they used inappropriate statistics, and they even included women in these studies that were supposed to be looking at men with testosterone therapy,” Bernie said.
She added, “I specifically mentioned the TRAVERSE trial as well, because I think that that helps give patients a lot of [reassurance], because they recognize that it's a large, randomized, controlled trial that showed safety in men who already were high risk for cardiovascular disease.”
When asked to provide a piece of advice to urologists regarding the labeling changes, Bernie said, “Let's all know now that testosterone therapy does not result in increased cardiovascular risk. I hope that these new guidelines and the removal of the black box warning on testosterone therapy will help more physicians feel comfortable providing testosterone therapy to men, because there's a significant number of men in the United States and worldwide who have low testosterone levels and are extremely symptomatic who could benefit greatly from being prescribed testosterone therapy.”
REFERENCE
1. FDA issues class-wide labeling changes for testosterone products. News release. FDA. February 28, 2025. Accessed March 3, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products
