FDA testosterone labeling changes: How will they affect prescribing?

Following the FDA’s class-wide labeling changes for testosterone products,¹ John P. Mulhall, MD, was asked how these changes might affect patient counseling and shared decision-making regarding testosterone therapy.

“In a practice like mine, where approximately 30% of the practice is low testosterone, it'll have actually very little negative effect, because we have a discussion [and] have had a discussion for the past decade with our patients about the limitations in the Basaria, Vigen, and Finkle papers that have colored the thinking about MACE [major adverse cardiovascular events] and testosterone therapy. The overwhelming majority of the evidence that preceded those papers, and all of the evidence that has come after those…suggests that actually, testosterone therapy is not a concern, and that's been confirmed in the TRAVERSE study,” said Mulhall, a urologic surgeon at Memorial Sloan Kettering Cancer Center in New York, New York who chaired the guidelines committee for the American Urological Association’s “Evaluation and Management of Testosterone Deficiency” guideline.

Mulhall added, “Basically, it will not change my practice very much at all, but in routine urological practice and in primary care, what this should translate into is a comfort level among physicians to prescribe testosterone therapy, knowing that testosterone therapy is not associated with the development of major adverse cardiovascular events.”

Mulhall was also asked, with the FDA requiring product-specific blood pressure data on labels, whether he anticipated changing his prescribing habits based on the specific formulation of testosterone.

“We routinely check blood pressure. We see no major problems with the 3- to 5-point elevation most commonly seen in men who are on intramuscular testosterones, [although] it has been seen in oral therapy and in transdermal therapy. So I see no change in my clinical practice, but it does suggest to clinicians prescribing testosterone that you should get a baseline [blood pressure] and then follow up with your patients. We monitor their blood pressure, and if, for some reason, somebody on testosterone therapy has an alarming change in their blood pressure, their blood pressure physician, their primary care physician or cardiologist or an internist should be need made aware at least that they're on testosterone therapy,” Mulhall 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