An expert discusses patient counseling in wake of FDA’s labeling changes for testosterone

With the FDA’s recent class-wide labeling changes for testosterone products¹, urologist Landon Trost, MD, told Urology Times® it will be easier for clinicians to counsel patients regarding testosterone therapy.

“It definitely makes it easier for providers, because even if, as a provider, you know that there's not a really high risk, you feel obligated to go into an extended discussion on potential risks of cardiovascular [events] because if your patient is that 1 very low-risk patient who has a myocardial infarction or something—which may not even be related to testosterone—that patient's now going to come back and say, ‘Hey, you put me on testosterone. I had a heart attack. It's because of this; the FDA had a black box [warning]. You didn't warn me enough about it. I didn't understand the risks.' ”

Trost, founder and director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, was also asked whether, with the FDA requiring product-specific blood pressure data on labels, he anticipated changing his prescribing habits based on the specific formulation of testosterone. He said, “I don't think so. I don't think this will lead to many changes in clinical practice as far as I don't think you'll start to see people getting routine blood pressure measurements or anything like that. The absolute increases in blood pressure with these studies was very mild. I think it's something you mention [to patients]. I think it's something you screen for…I think it's something to be aware of, something to note, but it's not like you're seeing a 30-point jump in blood pressure. These are very, very mild. And so it's again, something to be aware of, but it won't necessarily have dramatic impacts on practice.”

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