Opinion
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John P. Mulhall, MD, shares his reaction to the FDA’s testosterone labeling changes
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“In 5200 men, very clearly, definitively, irrefutably, it has been shown that testosterone therapy is not associated with MACE over the course of the 12 to 24 months after commencement of testosterone therapy," says John P. Mulhall, MD.
In light of the FDA’s recent announcement of class-wide labeling changes for testosterone products,1 John P. Mulhall, MD, is hopeful the American Urological Association (AUA) will update its guidelines regarding the use of testosterone therapy.
Mulhall, a urologic surgeon at Memorial Sloan Kettering Cancer Center in New York, New York who chaired the guidelines committee for the AUA’s “Evaluation and Management of Testosterone Deficiency” guideline, explained in an interview with Urology Times®, “It's very important to understand that the AUA guidelines are a systematic review with a meta analysis, so we looked at the world's literature. The problem is that in there, there were a very small number of papers—4, in fact—that tarnished the view about testosterone and MACE [major adverse cardiovascular events], suggesting that testosterone therapy was associated with MACE.”
Despite these papers being “massively methodologically flawed,” according to Mulhall, the FDA applied a black box warning to testosterone therapies citing cardiovascular risks. This warning, Mulhall said, “deprived many men of testosterone therapy, because physicians understandably were concerned about giving testosterone therapy.”
Later, the FDA mandated the conducting of the TRAVERSE study to investigate testosterone therapy and MACE. The study, Mulhall, said, “was powered to answer the question: Is testosterone therapy associated with major adverse cardiovascular events?”
“In 5200 men, very clearly, definitively, irrefutably, it has been shown that testosterone therapy is not associated with MACE over the course of the 12 to 24 months after commencement of testosterone therapy,” Mulhall said.
He added, “It is my hope that the AUA will, in short order, go back and change that statement, so that we now have guideline-based instructions to physicians that will say, you are now allowed to say to patients that testosterone therapy is not associated with major adverse cardiovascular events.”
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
