Helen L. Bernie, DO, MPH, on the FDA’s labeling changes for testosterone products

The FDA’s recent announcement of class-wide labeling changes for testosterone products was met with excitement by urologist Helen L. Bernie, DO, MPH.

“I'm so excited about them finally removing this boxed warning. I think that's been so important, and I think it's something that many of us who prescribe testosterone therapy often have known for a long time, so it's just nice to finally see this down in paper,” 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.

The labeling changes were made based on findings from the phase 4 TRAVERSE trial (NCT03518034) as well as results from required postmarket ambulatory blood pressure monitoring (ABPM) studies.¹

In an interview with Urology Times®, Bernie said she didn’t anticipate a change in her prescribing habits following the news.

“It's really not going to impact my practice much at all, because, again, I've [believed for a] while that…testosterone [does not] increases cardiovascular risk, and I'm just very glad that they've removed that labeling. I prescribe all patients testosterone therapy if they're symptomatic and they have documented low testosterone levels. I follow the AUA [American Urological Association] guidelines that came out in 2018 on testosterone management,” she said.

In the interview, Bernie also discussed blood pressure monitoring in patients receiving testosterone therapy.

“When I start [patients] on testosterone therapy, especially if they already have a history of high blood pressure, I remind them to make sure that they're prudent and are taking their blood pressure medications. And for anyone, regardless of whether they're on medication for blood pressure, I tell them, about once a week, go get your blood pressure checked the first 4 weeks that I start you on testosterone therapy, regardless of the modality. That really gives us an idea of what kind of changes they can expect to see while they're on testosterone therapy,” Bernie said.

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